FDA Action Alert: Verrica, BMS and Eton Negotiate With the FDA
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The U.S. Food and Drug Administration is wrapping up the month of May with a few PDUFA dates, although dates have shifted due to several different reasons. Here’s a look.
Verrica’s Resubmission for Molluscum Contagiosum
Verrica Pharmaceuticals has a target action date of May 24, 2022, for the resubmission of its New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum. VP-102 is a proprietary drug-device combination that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered using a single-use applicator. Molluscum contagiosum is a common, highly contagious skin disease that affects about 6 million people in the U.S., primarily children. If approved, it will be marked under the brand name Ycanth.
The company has also successfully completed a Phase II trial of the drug to treat common warts and a Phase II trial for the treatment of external genital warts.
Verrica originally received a Complete Response Letter (CRL) from the FDA in September 2021. It originally had a target action date of June 2021. Still, the agency had pushed the date back three months to allow time to review additional information it requested from Verrica.
The CRL found deficiencies at a facility of a contract manufacturing organization (CMO) that weren’t explicitly related to the manufacturing of VP-102 but did present quality issues for the facility. No clinical, safety or product-specific CMC deficiencies related to the drug were identified.
At Verrica’s first-quarter financial report on May 9, Ted White, company president and CEO said, “We look forward to potentially bringing treatment and relief to thousands of patients, primarily children, suffering from molluscum, starting with a sales focus in Dermatology, Pediatric Dermatology and key academic centers and health systems.”
Bristol Myers Squibb’s Opdivo Plus Yervoy for Esophageal Squamous Cell Carcinoma
Bristol Myers Squibb has a target action date of May 28 for its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatments for adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). The submission was built on results from the Phase III CheckMate -648 trial.
Opdivo is an anti-PD-1 immune checkpoint inhibitor. Yervoy is an anti-CTLA-4 immune checkpoint inhibitor.
“Last year, over 19,000 people were diagnosed with esophageal cancer in the United States, and 15,000 people died as a result of this very aggressive disease,” Dr. Ian M. Waxman, M.D. said, development lead, gastrointestinal cancers, BMS. “Additional treatment options are needed to improve upon outcomes achieved with the current standard of care. We are confident that our immunotherapy-based combinations can provide further clinical benefit and address this critical need.”
Eton’s Zonisamide for Partial Seizures in Patients with Epilepsy
Eton Pharmaceuticals had a target action date of May 30 for zonisamide oral suspension for the treatment of partial seizures in patients with epilepsy. The drug initially had a PDUFA date of May 29, 2021, but the FDA issued a CRL because it couldn’t inspect the manufacturing site because of COVID-19-related travel restrictions. The agency inspected the facility in January 2022.
In its’s first-quarter financial report on May 12, Eton reported that the drug’s contract manufacture site inspection had been officially closed in April and was deemed ready for commercial manufacturing. There was a newly assigned PDUFA date of July 18.