Concert Pharmaceuticals receives FDA Green Signal for Hair Loss Drug

Concert Pharmaceuticals receives FDA Green Signal for Hair Loss Drug

The U.S. FDA has lifted clinical hold on Concert Pharmaceuticals’ trial for a hair loss drug. The company informed that FDA has lifted clinical hold on the treatment for alopecia areata. The trial was put on hold by FDA in May this year.

FDA asked Concert Pharmaceuticals to provide more data before the company could provide dosage of its experiment drug to study subject. The company added that FDA had not raised any concerns about safety of its drug.

The drug has been developed for treatment of moderate-to-severe condition of alopecia areata. The company informed that it will make some changes to its study plan. The company plans to enroll 90 patients for the initial trial of the drug. The company will start with enrollment of study subjects later this month.

Patients will be provided with either 4 mg or 8 mg dosage of the medicine, to be taken twice a day. Concert Pharmaceuticals aims to finish the study by mid of next year. The trial will run for 24 weeks, the company informed.

The condition impacts nearly 4.6 million people in the United States. Alopecia areata is an autoimmune disorder in which the immune system attacks hair follicles, resulting in patchy or complete hair loss on the scalp and body.

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