The US Food and Drug Administration (FDA) declined to approve Verrica Pharma’s drug for the treatment of a viral skin disease known as molluscum contagiosum, the company said recently.
The disease is caused by a pox virus and leads to skin-toned to pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. While the lesions usually go away within a year without scarring, some cases could take a lot more time.
There are currently no approved treatments in the US for the condition.
The FDA denied approval for Verrica’s drug VP-102 due to deficiencies identified at Sterling Pharmaceuticals Services, a contract manufacturer that produces Verrica’s bulk solution drug product, during a general re-inspection, which resulted in an Official Action Indicated (OAI) status.
An OAI is the FDA’s most serious category of violation, and regulatory experts say it could lead to a prohibition on the sale of drugs from a facility, if not addressed.
Verrica said it had been told that internal policy is preventing the health regulator from “communicating the label and approving the New Drug Application (NDA) when a contract manufacturer is placed on OAI status.
None of the issues identified by the FDA during its re-inspection were specific to the manufacturing of VP-102, Verrica said in its statement.
The health regulator had declined Verrica’s marketing application for the drug last year, citing general quality issues at one of the company’s third-party manufacturing facilities.
Edits by EP News Bureau