US FDA declines to authorise Verrica’s viral skin disease treatment

There are currently no approved treatments in the US for the condition

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

US FDAVerricaviral skin disease treatment
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