On 15 January 2019, Clinuvel Pharmaceuticals Limited (ASX: CUV) announced major timelines for the FDA approvals on the overall benefit-risk assessment of SCENESSE® (afamelanotide 16mg), company’s flagship photoprotective drug for the prevention of phototoxicity in adults with the erythropoietic protoporphyria (EPP) disease.
Below are the important dates for SCENESSE® US regulatory approval:
- 9 January 2019- The US Food and Drug Administration (FDA) completed the review of the New Drug Application filed by the company in June 2018.
- 8 April 2019- FDA will be sharing labelling and post-marketing requirements and commitments if needed
- 8 July 2019 – Target review date under the Prescription Drug User Fee Act (PDUFA).
Clinuvel is anticipating increased interactions with FDA this year in terms of possible questions on the individual scientific modules submitted such as pre-clinical and clinical product data, quality aspects, manufacturing process and distribution activities of the product in the US. The FDA has already examined the US manufacturing site of SCENESSE®. Further inspections of US clinical sites are ongoing to determine GCP compliance. The company understands that the regulatory approvals are time-consuming, however, it highlights the benefits its clinical teams have derived by adding more safety measures to SCENESSE® dossier.
On December 2018, Clinuvel released the findings of CUV103 study in vitiligo patients which demonstrated that the combination of SCENESSE® with narrowband UVB (NB-UVB) results in a follicular pigmentary response among Asian vitiligo patients. As suggested by FDA, the company conducted a pre-clinical study to access the scope of this combination therapy and observed that NB-UVB directed thrice a week and SCENESSE® administered once in four weeks over six months, did not pose any safety concerns. The company is targeting further work for the future of SCENESSE in vitiligo treatment and would keep the medical community and patients informed of the developments.
Post the FDA’s review process in EPP, the vitiligo program will be conducted in North America. The company also plans to conduct a Type C meeting with the Division of Dermatology and Dental Products for the protocol design and advanced development roadmap for SCENESSE® establishment in the US market.
Clinuvel has announced an experimental study as part of the clinical expansion of SCENESSE® in Variegate Porphyria (VP) patients. VP belongs to the family of 9 porphyrias disabling patients with skin fragility, frequent ulcerations and blistering. The company has received the initial regulatory approvals for Phase II study - CUV040, first photoprotective clinical study in VP patients since 1970s. This will involve procedures conducted on six VP patients for eight months, with up to six SCENESSE® implants administered over a six-month period. The study is expected to begin soon this year.
Clinuvel is looking forward to unveiling further work from the VALLAURIX team later this year. The company is also keeping an eye on its UK market presence given uncertain UK’s Brexit plans.
Clinuvel shares are trading in red today at the price of A$21.880, down by 1.63% (As at 2:03 PM, 15 January 2019). The company’s stock has demonstrated impressive performance over last six months, offering a return of 98.13% to investors.
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