Q1 Accepted NDAs and sBLAs to Keep a Watchful Eye On

The first quarter of 2023 continued with the ongoing boom in new dermatologic drugs and therapies with the acceptance of 3 new therapies and their Prescription Drug User Fee Act (PDUFA) dates:

• Verrica Pharmaceuticals’ VP-102 for the treatment of molluscum contagiosum – PDUFA July 23, 2023
• Bristol Myers Squibb’s nivolumab for the treatment of completely resected stage IIB or IIC melanoma – PDUFA October 13, 2023
• Novan Inc.’s berdazimer gel, 10.3% for the treatment of molluscum contagiosum – PDUFA January 5, 2024

VP-102

The US Food and Drug Administration (FDA) accepted Verrica Pharmaceuticals’ resubmitted New Drug Application (NDA) on February 27, 2023, for VP-102 (cantharidin 0.7%) for the treatment of molluscum contagiosum after 3 previously submitted Complete Response Letters (CRL). The FDA cited concerns about labeling, post-marketing requirements, and the quality of Verrica’s contract manufacturing organization among the initial CRLs. With an assigned PDUFA date of July 23, 2023, VP-102 could be the first FDA-approved treatment for molluscum contagiosum. Verrica and Novan Inc. have been in constant competition with one another to have the first approved molluscum contagiosum treatment, which primarily affects children.

Nivolumab

Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) of nivolumab for the treatment of completely resected stage IIB or IIC melanoma was accepted by the FDA on February 28, 2023. The FDA assigned Bristol Myers Squibb a PDUFA date of October 13, 2023. Additionally, the European Medicine Agency also validated the Type II Variation Marketing Authorization Application for nivolumab. Nivolumab is already approved to treat 19 various types of cancer, including advanced melanoma and previously treated squamous cell carcinoma of the head and neck.¹ The FDA’s acceptance was based on safety and efficacy data of the pivotal phase 3 trial, CheckMate – 76K. 

Berdazimer Gel, 10.3%

Lastly, the FDA approved Novan Inc.’s NDA of berdazimer gel, 10.3% for the treatment of molluscum contagiosum on March 7, 2023. The FDA has assigned Novan a January 5, 2024, PDUFA date. The acceptance of berdazimer gel follows closely behind Verrica’s VP-102 acceptance, as both companies vie to produce the first FDA-approved treatment. In the phase 3 BSIMPLE4 clinical trial, berdazimer gel demonstrated statistically significant improvement in complete clearance of all treatable molluscum contagiosum at week 12. Study authors John C. Browning, MD, MBA, and colleagues noted that molluscum contagiosum may persist for months to years and can significantly affect a patient’s quality of life.²

What’s Next? 

Regarding the ongoing competition between Verrica Pharmaceuticals and Novan Inc., both hope to provide the first-ever FDA-approved molluscum contagiosum treatment for their patients. Shanna Miranti, MPAS, PA-C, a board-certified physician assistant at Riverchase Dermatology in Naples, Florida, recently spoke to Dermatology Times® regarding the race for VP-102 and berdazimer gel.

“It is a very exciting time in pediatric dermatology right now. We have 2 pharmaceutical companies essentially in a race to the finish to get the very first FDA-approved treatment for molluscum contagiosum,” said Miranti. “I'm sure that a lot of dermatology advanced practice providers like myself will be extremely excited to get our hands on these products. Because right now there's nothing FDA-approved for molluscum. It's amazing to think about how molluscum affects 6 million Americans and over 70% go untreated because they just think that they’re just bumps, or they think they're cosmetic, or because they're not causing any pain, they're not such a problem. But it is a contagious condition. It's something that because I work in pediatric dermatology and general dermatology, I see it every single day.”

As the first PDUFA dates of July 23 for VP-102 and October 13 for nivolumab approach in 2023, it’s crucial for dermatologists and advanced practice providers to keep a watchful eye on FDA approvals and how they can bring these much-needed treatment options to their patients. Follow along with all drug approvals by subscribing to Dermatology Times’ eNewsletters and by keeping up with the latest approval news on our website.

References

1. Full indications. Opdivo. Updated August 2022. Accessed March 29, 2023. https://www.opdivo.com/
2. Browning JC, Enloe C, Cartwright M, et al. Efficacy and safety of topical nitric oxide−releasing berdazimer gel in patients with molluscum contagiosum: A phase 3 randomized clinical trial. JAMA Dermatol. 2022;158(8):871–878. doi:10.1001/jamadermatol.2022.2721