The ID Pipeline: FDA Activity From the Week of November 24, 2019
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of November 24, 2019.
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of November 24, 2019.
Emergent BioSolutions Announces Positive Immunogenicity Results From Phase 2 Study of Its Investigational Chikungunya VLP Vaccine Candidate
Emergent BioSolutions Inc. presented updated results from the interim analysis of its Phase 2 clinical study evaluating the safety and immunogenicity of the company’s chikungunya virus virus-like particle vaccine candidate. The interim analysis showed that after administration of the first dose, up to 98% of study participants produced a neutralizing antibody response against the chikungunya virus within seven days after vaccination.
The immune response also persisted for at least one year for subjects who received a single dose. Results were presented at the American Society of Tropical Medicine and Hygiene annual meeting in Maryland, held from November 20 to 24, 2019.
Read the full press release here.
Verrica Pharmaceuticals Announces FDA Filing Acceptance of New Drug Application for VP-102 for Molluscum Contagiosum
Verrica Pharmaceuticals announced that the FDA has accepted its New Drug Application for VP-102 (cantharidin 0.7% Topical Solution), a topical therapy for the treatment of molluscum contagiosum. The Prescription Drug User Fee Act goal date assigned for the New Drug Application is July 13, 2020.
There are not currently FDA-approved treatments available for patients diagnosed with molluscum, meaning VP-102 has the potential to be the first FDA-approved treatment for a viral skin infection which affects approximately 6 million people in the United States.
The New Drug Application was based on positive results from 2 identical Phase 3 randomized, double-blind, multicenter clinical trials that evaluated safety and efficacy of VP-102 compared to placebo in patients diagnosed with molluscum contagiosum. In both trials, a statistically significant number of patients treated met the endpoint of complete clearance of all treatable molluscum lesions.
Read the full press release here.
