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Verrica Pharmaceuticals receives CRL from FDA identifying deficiencies at a facility of a CMO for its NDA for VP-102.
Verrica Pharmaceuticals, a dermatology therapeutics company, announced FDA issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) in a Sept. 20, 2021, press release. Previously, FDA extended the Prescription Drug User Fee Act goal date for the NDA by three months (to September 23, 2021) to allow FDA additional time to review information submitted by Verrica in response to comments from FDA regarding the company’s human factors study.
FDA identified deficiencies at a contract manufacturing organization (CMO) facility in the CRL, which—according to the company press release—are not directly related to the manufacturing of VP-102. Instead, these deficiencies raise general quality issues at the facility. The company adds in the press release that, prior to the CRL, they had not been notified by FDA of any deficiencies at the CMO related specifically to the manufacturing of VP-102 or that their general investigation of the facility would have any impact on the NDA. To date, FDA did not identify any clinical, safety, or product specific chemistry, manufacturing, and controls deficiencies related to VP-102.
The CMO working with Verrica has implemented corrective actions to address FDA’s concerns, according to the press release, and the CMO has advised Verrica that it is expecting a satisfactory resolution of the facility’s identified deficiencies within the next 30 business days. During this timeframe, Verrica says they will engage with FDA to demonstrate that their good manufacturing practices, controls, and processes ensure that any deficiencies at the CMO do not impact the efficacy, safety, or quality of VP-102.
“We remain confident that we have a path forward for VP-102 as a potential treatment option for molluscum, a highly contagious viral skin disease affecting approximately six million people in the United States—primarily children—for which there are currently no FDA-approved treatments,” said Ted White, president and CEO, Verrica, in the press release.
Source: Verrica Pharmaceuticals