FDA rejects Valeant treatment for psoriasis

Federal health regulators have declined to approve a lotion developed by Valeant Pharmaceuticals to treat plaque psoriasis, a common skin condition.

The Food and Drug Administration did not point to anything lacking in the safety or efficacy of the treatment, called Duobrii, Valent said in a statement on Monday. The agency’s letter “only noted questions regarding pharmacokinetic data,” Joseph Papa, Valeant’s chairman and CEO, said.

Valeant shares fell nearly 7 percent in early morning trade after news of the FDA denial came out.

The drugmaker has asked for a meeting with the FDA to settle the matter, which Valeant hopes to resolve quickly, the company said.

Plaque psoriasis causes dry, itchy patches on the skin, with symptoms including a rash. About 7.5 million Americans suffer from psoriasis, according to the American Academy of Dermatology.

© 2018 CBS Interactive Inc.. All Rights Reserved.

Categories: Health

Leave a Reply

Your email address will not be published. Required fields are marked *