CMO issues thwart Verrica’s attempts at a drug approval

Sept. 22, 2021

Pennsylvania-based Verrica Pharmaceuticals was so close to finally getting an approval for its lead drug candidate — but once again it has run into a roadblock at the FDA.

This week, the company announced that the FDA has issued a Complete Response Letter to the company for its drug, VP-102, which was developed to treat molluscum contagiosum, a skin disease that impacts about 6 million people in the U.S. each year.

According to the company, the FDA did not raise concerns about the safety or efficacy of the drug. Rather, the agency said that it has identified quality deficiencies at the CMO producing VP-102. The specific quality concerns are not related to the manufacturing of VP-102, and Verrica said that its manufacturer is now taking steps to remedy the issues with the FDA. 

Verrica has been on a bumpy road to its potential approval of VP-102. Its initial application for the drug in 2019 was rejected by the agency due to certain aspects of the chemistry, manufacturing and controls process.

If VP-102 makes it past the finish line, it will mark the first drug approval for Verrica, which was founded in 2013 and specializes in dermatology therapeutics.