Posted by Michael Wonder on 07 Sep 2019
FDA approves first treatment for patients with rare type of lung disease
6 September 2019 - The U.S. FDA today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD.
It is the first FDA approved treatment for this rare lung condition.
Ofev received priority review designation, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition. Ofev also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
