Verrica hits another bump in the road with CMO related letter from FDA
The FDA has rejected Verrica’s new drug application for VP-102 again, with the company pinning the CRL on problems at a CMO that it was partnered with, the company announced Monday.
The FDA didn’t raise issues that directly relate to the manufacturing of VP-102, the company said, but raised “general quality issues” at the CMO’s facility. There were also no clinical concerns, it said, or need to collect more data.
“At no time prior to the CRL was the Company notified by the 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 Company’s NDA,” the press release said. “More importantly, the FDA did not identify any clinical, safety or product specific Chemistry, Manufacturing, and Controls (CMC) deficiencies related to VP-102.”
Verrica says that it has gotten word from the CMO that corrective action is underway at the site, and it’s expecting a solution within the next 30 days. CEO Ted White said in a press release that he and his staff remain confident that there is a path forward for VP-102. The company said it will collaborate with the CMO to ensure that the efficacy, safety and quality of the drug aren’t impacted.
As of now, it is unclear which CMO has been chided by the FDA, as Verrica didn’t respond by publication time to a request for comment.
VP-102 is a treatment for molluscum contagiosum, a virus that causes raised bumps or lesions on the upper layers of a person’s skin. The disease affects 6 million people in the US, mostly children, and can last longer than a year without treatment. It was also being tested for the use on common warts, which recently completed a Phase II study, and genital warts, which also just completed Phase II.
The biotech announced in May that the FDA had delayed its PDUFA date from June 23 to Sept. 23, as regulators needed more time to review the training program and distribution model.
That was a part of its second go-around at the agency, after VP-102 was rejected in July 2020 after the FDA said that it wanted more information on chemistry, manufacturing and controls, along with human factors. A safety issue could arise, the FDA said, if healthcare workers didn’t carefully follow instructions.
In 2018, the company landed a $75 million IPO, on the claim that they could develop the first FDA-approved drug for molluscum contagiosum. The company is also developing VP-103 for the treatment of plantar warts, and LTX-315 for the treatment of dermatologic oncology conditions.