Valeant psoriasis treatment rejected by FDA

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.

f

We and our partners use cookies to understand how you use our site, improve your experience and serve you personalized content and advertising. Read about how we use cookies in our cookie policy and how you can control them by clicking Manage Settings. By continuing to use this site, you accept these cookies.