ID Year in Review: FDA Approvals of 2019

Here is a look back at approvals, clearances, and authorizations granted by the US Food and Drug Administration (FDA) for infectious disease products in 2019 in no particular order.

Antibiotics, Drugs, and Treatments:

Dolutegraivr/Lamivudine Approved for Treatment-Naïve Patients With HIV

The FDA issued an approval for dolutegravir and lamivudine (Dovato), as a complete regimen for treatment-naïve adults with HIV-1.

This marks the first FDA-approved 2-drug, fixed-dose, complete regimen for treatment-naïve adults with HIV, according to the press release.

"Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug," Debra Birnkrant, MD, director of the Division of Antiviral Products, said in the statement. "Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time."

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Cefiderocol Approved for Treatment of cUTI

The FDA approved cefiderocol (Fetroja) for the treatment of complicated urinary tract infections (cUTI), including kidney infections caused by susceptible gram-negative microorganisms in adults, who have limited or no alternative treatment options. The approval was granted to Shionogi Inc.

Cefiderocol is a siderophore cephalosporin. It is active against all classes of β-lactamases, which enables it to overcome the primary mechanisms of gram-negative bacterial resistance to β-lactam antibiotics.

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Label Expansion Approved for Ceftazidime and Avibactam

The FDA approved a supplemental New Drug Application (sNDA), expanding the label for ceftazidime and avibactam (AVYCAZ) to include pediatric patients 3 months and older for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) in combination with metronidazole.

Ceftazidime/avibactam is a fixed-dose combination antibacterial. Avibactam is a non-beta-lactam beta-lactamase inhibitor, which protects ceftazidime from degradation by some beta-lactamases. Avibactam does not decrease the activity of ceftazidime against ceftazidime-susceptible organisms. Ceftazidime is a third-generation cephalosporin with a well-established efficacy and safety profile

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Glecaprevir and Pibrentasvir Approved for HCV Treatment in Children

The FDA announced the approval of AbbVie Inc.'s Mavyret (glecaprevir and pibrentasvir) for the treatment of all 6 genotypes of hepatitis C virus (HCV) in pediatric patients aged 12 to 17 years. The tablets were approved to treat adults 18 years and older in 2017.

According to dosing information that was released with the announcement of the approval, the agent should be administered to adult or pediatric patients 12 years and older, or weighing at least 99 pounds, who are infected with any of 6 identified HCV genotypes either without cirrhosis or with compensated cirrhosis.

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FDA Approves Ceftolozane/Tazobactam for HABP/VABP

The FDA announced the approval of ceftolozane/tazobactam for the treatment hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). The approval of this new indication was granted to Merck & Co., Inc.

Ceftolozane/tazobactam (Zerbaxa) is a combination treatment of an anti-pseudomonal cephalosporin, ceftolozane, and an extended-spectrum β-lactamase inhibitor, tazobactam. In the United States ceftolozane/tazobactam is indicated for the treatment of complicated urinary tract infections including pyelonephritis caused by certain susceptible Gram-negative microorganisms and also in combination with metronidazole for the treatment of complicated intra-abdominal infections. It was first approved by the FDA in 2014.

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Imipenem/Cilastati + Relebactam Approved for cUTI and cIAI

The FDA approved imipenem/cilastatin + relebactam (Recarbrio) for the treatment of complicated urinary tract infections and complicated intra-abdominal bacterial infections in adults who have limited or no alternative treatments available.

A new drug application (NDA) was accepted in February for the combination of relebactam, Merck’s investigational beta-lactamase inhibitor, with imipenem/cilastatin for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible gram-negative bacteria.

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Treatment for Resistant Forms of TB Approved

The FDA announced the approval of pretomanid tablets in combination withbedaquiline and linezolid for the treatment of highly treatment-resistant tuberculosis. The novel compound, pretomanid, was developed by the TB Alliance.

The approval was granted under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) as a 3-drug, 6-month, all-oral regimen for individuals with extensively-drug resistant (XDR) or multidrug-resistant (MDR) tuberculosis who are treatment intolerant or non-responsive to treatment. Pretomanid is only the third new anti-TB drug approved for use by FDA in more than 40 years.

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Lefamulin Approved for CABP

The FDA approved lefamulin (Xenleta) for the treatment of community-acquired bacterial pneumonia (CABP) after results from 2 phase 3 studies showed the novel pleuromutilin antibiotic to be non-inferior to existing treatment options.

“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease,” said Ed Cox, MD, MPH, director of FDA’s Office of Antimicrobial Products in a statement issued by the FDA. “For managing this serious disease, it is important for physicians and patients to have treatment options. This approval reinforces our ongoing commitment to address treatment of infectious diseases by facilitating the development of new antibiotics.”

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F/TAF (Descovy) Approved for PrEP in MSM, Transgender Women

The FDA approved emtricitabine 200 mg and tenofovir alafenamide 25 mg (F/TAF; Descovy) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection through sex, excluding those who have receptive vaginal sex. The approval was granted to Gilead Sciences.

F/TAF is not indicated in individuals at risk of HIV infection from receptive vaginal sex because the effectiveness in this population has not been evaluated.

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Expanded Indications Approved for Pifeltro and Delstrigo

The FDA approved 2 supplemental New Drug Applications (sNDA) for doravirine (Pifeltro) and doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo). The approval allows treatment-experienced adults living with HIV, who are virally suppressed and have no prior history of treatment failure, to switch to either of the treatment options. The approval was granted to Merck.

Doravirine is a 100 mg, once-daily, non-nucleoside reverse transcriptase inhibitor (NNRTI), and doravirine/lamivudine/tenofovir disoproxil fumarate is a once-daily fixed-dose combination tablet of 100 mg doravirine, 3TC/300 mg lamivudine, and TDF/300 mg tenofovir disoproxil fumarate. Both were first approved by the FDA in August 2018 for adult patients with no documentation of past antiretroviral therapy.

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FDA Approves Premixed Vancomycin Injection

The FDA approved premixed vancomycin injections in a ready-to-use bag, Xellia Pharmaceuticals announced today. The approval comes a year after the FDA issued a Qualified Infectious Disease Product designation for the injection.

The vancomycin injection is a glycopeptide antibacterial that is indicated for pediatric patients older than 1 month and adults for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory infections.

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FDA Expands Approval for Glevaprevir and Pibrentasvir

The FDA expanded the approval of glecaprevir and pibrentasvir (Mavyret). Under the expansion, the tablets are now approved for an 8-week duration for treatment-naïve children ages 12 years and older and adults who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis. The approval was granted to AbbVie Inc.

According to the US Centers for Disease Control and Prevention, between 2.7 and 3.9 million people in the United States have chronic HCV, and children born to HCV-positive mothers are at risk for HCV infection. It is estimated that there are 23,000 to 46,000 children in the United States with HCV infection.

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FDA Approves Baloxavir Marboxil for Patients at High Risk of Flu Complications

The FDA approved a supplemental New Drug Application for baloxavir marboxil (Xofluza) for the treatment of influenza in individuals who are at increased risk of developing flu-related complications.

Baloxavir marboxil is a first-in-class, 1 dose oral agent that was first approved by the FDA in 2018 for the treatment of acute, uncomplicated influenza in individuals 12 years and older, who have been symptomatic for less than 48 hours. The medication had a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication. When it was approved in 2018, it became the first new antiviral to treat influenza in 20 years.

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Delafloxacin Approved for Treatment of CABP

The FDA approved a supplemental new drug application (sNDA) for Melinta Therapeutics' delafloxacin (Baxdela) for the treatment of adults with community-acquired bacterial pneumonia (CABP).

The approval is based on the results of a phase 3 randomized, double-blind study comparing the efficacy and safety of delafloxacin to moxifloxacin. The study results showed that IV-to-oral delafloxacin met the primary end point of statistical non-inferiority for early clinical response (ECR) at 96 hours (± 24 hours) after initiation in the intent-to-treat population with 88.9% ECR in patients who received delafloxacin compared to moxifloxacin (89.0%). Additionally, delafloxacin was generally safe and well-tolerated.

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RHB-105 (Talicia) Approved to Treat H Pylori

The FDA approved RHB-105 (Talicia) for the treatment of Helicobacter pylori in adults. The approval was granted to RedHill Biopharma Ltd.

H pylori affects approximately 35% of the United States adult population and is classified as a group 1 carcinogen. It is the strongest risk factor for the development of peptic ulcer disease, gastritis, and non-cardia gastric cancer.

Talicia is a 3-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial­­, and is a novel, fixed-dose, all-in-one delayed-release capsule 10 mg/250 mg/12.5 mg.

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Vaccines:

Ebola Vaccine Approved by FDA

The FDA announced that the Ebola vaccine Ervebo has been approved for administration in individuals 18 years of age and older. This is the first vaccine for the prevention of Ebola virus disease that has been authorized in the United States. The approval was granted to Merck & Co., Inc.

Ervebo is administered as a single-dose injection and is a live, attenuated vaccine.

“While the risk of Ebola virus disease in the US remains low, the US government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo,” said Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs in the FDA's statement.

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Dengvaxia Approved in the United States

The FDA announced the approval of the vaccine Dengvaxia for the prevention of dengue disease in children aged 9 to 16 years with a laboratory-confirmed case of previous dengue infection. Eligible individuals must live in an endemic region of the US, which include American Samoa, Guam, Puerto Rico and the US Virgin Islands.

Dengvaxia, produced by Sanofi Pasteur, is a live, attenuated vaccine, with an initial dose administered followed by 2 additional shots given 6 and 12 months later.

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Smallpox, Monkeypox Vaccine Approved

The FDA approved the first live, non-replicating vaccine indicated for the prevention of smallpox and monkeypox.

The Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, from Bavarian Nordic A/S, was approved for preventing smallpox and monkeypox in adults aged 18 years or older who have been determined to be at high risk for either infection.

With the indication, it also becomes the only FDA-approved vaccine for the prevention of monkeypox—a rare virus infection with similar, mild symptoms to smallpox. The possibly fatal disease last made headlines in the US during a 2003 outbreak, when the first human case was reported outside of Africa.

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Fluzone High-Dose Quadrivalent Flu Vaccine Approved for Older Adults

The FDA approved Sanofi’s Fluzone High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age and older. The vaccine will be made available for the 2020-2021 influenza season.

The approval of the supplemental Biologics License Application marks a transition from the company’s trivalent influenza vaccine first approved in 2009 that contained 2 influenza A strains and 1 influenza B strain. Fluzone High-Dose Quadrivalent contains an additional influenza B strain.

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FDA Approves Fluzone Quadrivalent Vaccine For Children 6-35 Months

The FDA approved the extended use of the Fluzone quadrivalent vaccine to include children age 6 through 35 months, Sanofi Pasteur has announced.

The approval grants authorization of use of the 0.5mL dose of the vaccine in young children. The dose will be available alongside the 0.25 mL dose for the 2019-2020 season for the young children included in this indication.

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FDA Approves Triclabendazole for Treatment of Fascioliasis

The FDA approved triclabendazole (Egaten) for the treatment of fascioliasis in patients aged 6 years and older.

The approval marks the first FDA-approved drug for this neglected tropical disease, which is commonly known as liver fluke infestation. Fascioliasis is caused by 2 species of parasitic flatworms, Fasciola hepatica or Fasciola gigantica, that can be transmitted to humans following consumption of larvae in contaminated water or food.

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Diagnostics:

FDA Permits Marketing of Mycoplasma Genitalium Test

The FDA permitted the marketing of a new test designed to aid in the diagnosis of Mycoplasma genitalium (M. gen), a sexually-transmitted infection(STI) prevalent in cases of continued male urethritis.

The Aptima Mycoplasma genitalium Assay, from Hologic Inc., was granted marketing approval upon the FDA’s review of clinical trial data showing its accuracy in 11,774 samples. In the trial, the assay correctly identified M. gen in approximately 90% of all vaginal, male urethral, male urine, and penile samples. In female urine it correctly identified the disease 77.8% of the time, and in endocervical samples, 81.5% of the time.

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Early Sepsis Indicator Cleared

The FDA granted 510(k) clearance for the Early Sepsis Indicator to Beckman Coulter. The Early Sepsis Indicator is hematology-based cellular biomarker designed to help emergency department physicians identify patients with sepsis or at an increased risk of developing sepsis.

The Early Sepsis Indicator is automatically reported as part of a routine complete blood count with different for adult emergency department patients. A positive result signals a higher probability of sepsis and a negative result signals lower probability of sepsis.

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FDA Clears Extragenital Tests for Chlamydia and Gonorrhea

The FDA approved marketing for 2 tests that can detect bacteria that cause chlamydia and gonorrhea through diagnostic testing of extragenital specimen. The 2 tests, Aptima Combo 2 Assay and Xpert CT/NG are the first devices cleared for testing for these sexually transmitted infections (STIs) via the throat and rectum.

Both the Aptima Combo 2 Assay and Xpert CT/NG were previously cleared by the FDA for testing urine, vaginal, and endocervical samples.

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Zika Antibodies Test Cleared for Marketing

The FDA authorized marketing of the ZIKV Detect 2.0 IgM Capture ELISA, the first diagnostic test to detect Zika virus immunoglobulin antibodies in human blood.

This test is the first Zika diagnostic test that the FDA has permitted to be marketed in the United States, as previous tests have only been authorized for emergency use. With this marketing authorization, the FDA has revoked the Emergency Use Authorization for this product, which was previously granted in 2016.

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HIV-1 Drug Resistance Test Authorized for Marketing

The FDA authorized marketing of the Sentosa SQ HIV Genotyping Assay, a test that detects HIV-1 drug resistance mutations using next-generation sequencing technology. The assay is the first HIV drug resistance test using next-generation sequencing technology to be authorized for marketing in the United States. The FDA granted the marketing authorization to Vela Diagnostics USA Inc.

The Sentosa SQ HIV-1 Genotyping Assay detects drug resistance mutations in patients who are undergoing or about to undergo antiviral therapy. The assay detects mutations in the genetics of HIV in a sample of blood using next-generation sequencing.

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First Duodenoscope With Sterile, Disposable Component Cleared

The FDA cleared the first duodenoscope with a sterile, disposable elevator piece for marketing. The disposable elevator component will reduce the number of parts required to be cleaned and disinfected between uses.

The Pentax Medical Video ED34-i10T2 model duodenoscope will allow visualization and access to the upper gastrointestinal tract for the treatment of bile duct disorders and other upper gastrointestinal problems. The clearance of the ED34-i10T2 was granted to Pentax of America.

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Marketing Authorization Granted for Novel MRSA Diagnostic Tool

The FDA granted marketing authorization for the cobas vivoDX MRSA diagnostic test. The authorization was granted to Roche Molecular Systems Inc.

The test is a new diagnostic tool that uses bacterial viability and a novel technology to detect bacterial colonization of Methicillin-resistant Staphylococcus aureus (MRSA).

The new test uses bacteriophage technology that is based on bioluminescence to detect MRSA from nasal swab samples. This process can be conducted in as little as 5 hours which expedites the current conventional culturing timeline of 24-48 hours.

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FDA Clears First Disposable Duodenoscope

The FDA cleared the EXALT Model D Single-Use Duodenoscope for marketing. This is the first fully disposable duodenoscope which is intended to provide visualization and access to the upper gastrointestinal tract. The clearance was granted Boston Scientific Corporation.

Traditionally duodenoscopes have been designed to withstand use for multiple patients. This requires the devices to be cleaned and disinfected in between uses in order to reduce the threat of infection. However, the design of the device made it a complex process to clean. If devices are not properly sanitized, contaminated tissue or fluid can persist in the device and transmit infections between patients.

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