FDA Sets Prescription Drug User Fee Act (PDUFA) Date For CLINUVEL’s SCENESSE®

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FDA Sets Prescription Drug User Fee Act (PDUFA) Date For CLINUVEL’s SCENESSE®

A global biopharmaceutical company, CLINUVEL Pharmaceuticals Limited (ASX: CUV) is in the process of getting approval from US Food and Drug Administration (FDA) for CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), a first-in-class drug targeting erythropoietic protoporphyria (EPP).

Today (i.e., 10 January 2019), the company announced that US Food and Drug Administration (FDA) Division of Dermatology and Dental Products has set a Prescription Drug User Fee Act (PDUFA) date of 8 July 2019 for SCENESSE®. The company has submitted a New Drug Application (NDA) for the use of SCENESSE® in the prevention of phototoxicity and anaphylactoid reactions in adult patients with EPP. Following the release of the announcement, the share price of the company soared by 4.167 percent by the end of the trading session, closing at A$20.

After the review of the NDA, the FDA will assess the risk-benefit profile of the product for the intended patient population. The company is expecting a scientific exchange with the FDA during the final review process in which the company will provide answers to regulatory questions on all aspects of the technical dossier.

The FDA had already informed that it is not planning to hold an advisory committee meeting during the final review of the New Drug Application regarding SCENESSE ®. And if required it would communicate the proposed labeling and post-marketing requirements to CLINUVEL by 8 April 2019.

Commenting on the NDA, the company’s Chief Scientific Officer, Dr. Dennis Wright told that the acceptance of the NDA is the result of patience and hard work from the Company’s team and medical community. Dr. Dennis further informed that the company will continue the open and constructive dialogue with the FDA in the coming weeks and months in order to reach a positive and landmark outcome for EPP patients on 8 July 2019.

During 2018, a very large number of EPP patients received treatment from CLINUVEL which is a testament to the work of the company’s team in Europe, which is working together with other healthcare professionals who are responsible for patient care.

The company is having a strict risk management plan, in which the company is collecting data on the use of the product with a major focus on safety. The data helps the company to understand how SCENESSE® is being used under real-world conditions and this approach will be replicated on the entry of SCENESSE® in the US.

During the September quarter of 2018, the company received Cash receipts $10.7 million which were 89 percent higher than the previous corresponding period. The company made net operating payments of $2.86 million. As at 30 September 2018, the company had a cash balance of $44.39 million.

Over the period of last six months, the share price of CLINUVEL Pharmaceuticals Limited increased by 70.82 percent as on 9 January 2019. The company has a market capitalization of circa $918.87 million as on 10 January 2019.


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