FDA hits Verrica with third CRL for lead drug candidate VP-102
FDA hits Verrica with third CRL for lead drug candidate VP-102
Published: May 25, 2022
By Vanessa Doctor, RN
BioSpace
Verrica Pharmaceuticals has received its third Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its New Drug Application for its molluscum contagiosum treatment candidate VP-102.
The first CRL was issued in July 2020, with the FDA seeking additional details on certain aspects of the chemistry, manufacturing and controls (CMC) process and Human Factors validation. The regulator did not identify any clinical deficiencies at the time, but the issues raised affected discussions on labeling and post-marketing requirements and commitments for the drug-device.
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While Verrica complied with what was asked and resubmitted its NDA, VP-102 was once again issued a CRL in September 2021. This time, the FDA identified some concerns at a facility of a contract manufacturing organization (CMO) which, while not directly related to the production of VP-102, raised general quality concerns about the location.
Verrica said that the regulator did not notify them of any deficiencies at the CMO or that its evaluation of the facility would affect VP-102’s application. The FDA also reportedly did not mention any clinical, safety or product-specific CMC issues in its CRL.
In the third and most recent letter, a result of a re-inspection conducted in February 2022, Verrica noted that none of the issues were specific to VP-102 and how it is manufactured. The third CRL only listed issues at the company’s CMO, Sterling Pharmaceuticals Services, which manufactures Verrica’s bulk solution product.
The re-inspection was done around 90 days after the FDA classified the facility as Voluntary Action Indicated (VAI). In addition, under the VAI, it was understood that the FDA would not recommend or take regulatory action against Sterling. It would not affect any pending marketing application mentioning the facility, and the approval of an application may depend on a pre-approval inspection.
“Based on the successful PAI of VP-102 at Sterling and our understanding that the Division was ready to communicate our label, we believe our NDA meets the statutory standards for approval and that any issues at Sterling do not impact the manufacturing, quality, efficacy, or safety of VP-102. However, we recognize that the Dermatology Division’s hands may be tied due to the reinspection issues at Sterling and thank them for their efforts working with us to date,” Ted White, Verrica president and CEO, said in a press release.
“Verrica is extremely disappointed in the Agency’s issuance of the CRL under the totality of these circumstances. However, as Verrica weighs all its options to bring the first FDA-approved treatment for molluscum, one of the largest unmet needs in dermatology, to the market as soon as possible, it will continue to work collaboratively with the Agency,” White added.
VP-102 is a drug-device combination that allows for precise topical dosing and targeted administration of cantharidin. If approved, it could become the first FDA-approved product to treat molluscum contagiosum, a highly contagious skin disease that affects around six million people in the U.S., primarily children. If Verrica gets the green light to sell in the U.S., VP-102 will be marketed under the brand name Ycanth.
Verrica will file a request for a Type A meeting with the FDA to clarify concerns and determine the next steps to finally move its product forward. The company is also looking for an additional CMO to act as its alternative supplier.
BioSpace source:
Reuters
