US FDA Declined Topical Gel of Amryt for Rare Skin Diseases


On Monday, 28th February 2022, the company ‘Amryt’ said, the Food and Drug Administration (FDA) of the United States has declined to approve the drug of the company for the treatment of a group of the rare skin diseases called as the epidermolysis bullosa, and the agency has also asked Amryt for the purpose of submitting the additional data confirming the effectiveness of the drug.

This decision has come after the US FDA had extended the review of the treatment in the month of November 2021 for the purpose of reviewing the additional analysis of the data that was previously submitted by the company, and the regulator of the United States had also asked for the new information on the drug.

The company ‘Amryt’ said, the company is intending to discuss with the US FDA regarding the nature of the data that has been required for addressing the concerns of the health regulator. The epidermolysis bullosa (EB) has been a disease causing the fragile skin that has been blistering and tearing easily, and currently, there has been no approved therapy for the condition, and the treatment for the EB disease has been usually involved for controlling the symptoms by using and also changing the bandages along with managing the itching and pain with the medications.

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The Oleogel-S10 has been a topical gel is containing the extracts of birchbark that is speeding up the healing process of the skin wounds in the patients with junctional and dystrophic EB.