The ID Pipeline: FDA Activity From the Week of June 23, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of June 23, 2019.

Novavax Inc. to Pursue Accelerated Approval Pathway for Licensure of NanoFlu™​​​​​​ Vaccine Candidate

On Thursday, June 27, 2019, Novavax Inc. announced plans to use the accelerated approval pathway for licensure of NanoFlu™, its nanoparticle seasonal influenza vaccine candidate. A phase 3 clinical trial is planned for fall 2019 with topline data expected in the first quarter of 2020.

The FDA made the pathway available to Novavax in a recent letter, according to a press release.

“NanoFlu’s encouraging results observed in prior clinical trials, which demonstrated improved immune responses against licensed comparators, provide us confidence in the future success of the Phase 3 clinical trial,” Gregory M. Glenn, MD, president of Research and Development of Novavax, said in a statement. “The accelerated approval pathway allows us to potentially obtain U.S. licensure more expeditiously, and ideally, deliver a greatly needed improved flu vaccine, which could reduce the tremendous medical and economic burden of influenza.”

The full press release is available here.

FDA Accepts BLA for Sanofi's Meningococcal Vaccine Candidate

On Thursday, June 27, 2019, the FDA accepted a Biologics License Application (BLA) for Sanofi's MenQuadfi^TM Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine candidate.

The BLA includes positive data from phase 2 and 3 US clinical trials. The intended indication is for the prevention of meningococcal meningitis in persons 2 years of age and older.

The target action date for an FDA decision is April 25, 2020.

The full press release is available here.

Verrica Pharmaceuticals Announces Positive Topline Results in Phase 2 Clinical Trial of VP-102 for Treatment of Common Warts

On Wednesday, June 26, 2019, Verrica Pharmaceuticals announced positive topline results from its COVE-1 phase 2 open label clinical study of VP-102 for the treatment of verruca vulgaris.

The study evaluated the safety and efficacy of VP-102 in 2 cohorts of subjects with up to 6 warts. Cohort 1 was conducted at a single site with 21 subjects age 2 years and older receiving up to 4 treatments with VP-102 at least 14 days between treatments with longer treatment intervals allowed at the discretion of the investigator depending on a specific subject’s clinical response. Cohort 2 was conducted at 4 sites with 35 subjects age 12 years and older receiving up to 4 treatments with VP-102 every 21 days.

A total of 51% of subjects in cohort 2 achieved complete clearance of all treatable warts, and the treatment was well-tolerated with no serious adverse events reported.

“This is exciting news for Verrica and our proprietary cantharidin product. Positive Phase 2 data of VP-102 for the treatment of common warts, after the successful Phase 3 results achieved with VP-102 for molluscum contagiosum, further increases our confidence in the broad clinical utility and large market potential of our lead product,” Ted White, president and Chief Executive Officer of Verrica, said in a press release. “We are progressing the development of VP-102 for a broad range of skin diseases. We intend to request an ‘End of Phase 2’ meeting with the FDA for the treatment of common warts, and remain on track to submit an NDA for the treatment of molluscum contagiosum later this year.”

The full press release is available here.

FDA Approves Generic Oseltamivir Phosphate Capsules

On Tuesday, June 25, 2019, the FDA approved Alembic Pharmaceuticals’ Abbreviated New Drug Application for oseltamivir phosphate capsules USP, 30 mg, 45 mg, and 75 mg.

According to a press release issued by Alembic, the products are the therapeutic equivalent to Genentech’s Tamiflu capsules.

The capsules are indicated for treating uncomplicated, acute illness due to influenza A and B infection. The capsules are approved for use in patients 2 weeks of age and older, who have been experiencing symptoms of influenza for less than 48 hours. The indication also includes prophylaxis of influenza A and B in patients 1 year and older.

According to the press release, oseltamivir phosphate capsules had an estimated market size of $647 million for 12 months ending in December of 2018 according to IQIVA.

The full press release is available here.

European Medicines Agency Validates Narbriva's Marketing Authorization Application for Lefamulin

On Monday, June 24, 2019, the European Medicines Agency (EMA) validated Nabriva Therapeutics' Marketing Authorization Application for the intravenous (IV) and oral formulations of lefamulin, a potentially first-in-class, semi-synthetic pleuromutilin antibiotic for the treatment of community-acquired pneumonia (CAP) in adults 18 years of age and older.

If approved by the EMA, Nabriva will receive marketing authorization in all 28 member states of the European Union, as well as Norway, Liechtenstein, and Iceland.

“We are grateful for the EMA’s quick validation of our MAA submission and look forward to working with the EMA during the MAA review process. We are committed to providing European patients with CAP the potential option of short course treatment with IV or oral lefamulin” Jennifer Schranz, MD, Chief Medical Officer of Nabriva Therapeutics, said in a press release.

Nabriva's New Drug Application for lefamulin is currently under review by the US Food and Drug Administration with an assigned Prescription Drug User Fee Act (PDUFA) action date of August 19, 2019, for both the IV and oral formulations.

The full press release is available here.