(Reuters) - The U.S. Food and Drug Administration on Thursday approved Bausch Health Companies Inc’s topical plaque psoriasis treatment, which is expected to be a key revenue driver for the company.
Duobrii, which is priced at $825 for a 100-gram tube, is 50 percent lower than other branded topical treatments, the company said. It is expected to be available in the United States in June.
U.S.-listed shares of the company, formerly known as Valeant Pharmaceuticals, rose 3.5 percent to $23.82.
In June, the FDA had declined to approve Duobrii, seeking details on its pharmacokinetic data, which shows how the body reacts to a treatment, including the duration and intensity of the drug’s effects.
Since taking over from former Chief Executive Officer Michael Pearson in 2016, when erstwhile Valeant was hit by a flurry of investigations into its accounting and pricing practices, CEO Joseph Papa has worked to regain investor confidence and has been building on the company’s product portfolio.
The treatment is part of Bausch’s “Significant Seven”, a suite of seven key products expected to generate more than $1 billion in sales over the next five years.
Market for global psoriasis drugs is expected to touch $21.11 billion by 2022, according to U.S. consultant Grand View Research.
Psoriasis is a chronic condition that causes an overproduction of skin cells, resulting in inflamed, red lesions or plaques, which can be itchy and painful. As many as 7.5 million Americans suffer from plaque psoriasis disease.
The green signal from FDA for Duobrii comes after a similar plaque psoriasis lotion, Bryhali, was granted a tentative approval by the health regulator in October.
Reporting by Manojna Maddipatla and Aakash Jagadeesh Babu in Bengaluru; Editing by James Emmanuel