Nintedanib (Ofev) Gets EMA Panel Backing for IPF

European Union (EU) drug regulators have recommended approval of nintedanib (Ofev, Boehringer Ingelheim) for adults with idiopathic pulmonary fibrosis (IPF).

The EU decision comes roughly 5 weeks after the US Food and Drug Administration (FDA) gave the drug a green light.

IPF is an inflammatory, lung-scarring disease that reduces the transfer of oxygen into the bloodstream. Individuals with IPF experience a nagging cough, frequent lung infections, and shortness of breath that worsens over time, according to the European Medicines Agency (EMA).

As a kinase inhibitor, nintedanib blocks the receptors of multiple growth factors to inhibit lung fibrosis.

Before the decision by the EMA's Committee for Medicinal Products for Human Use (CHMP), the only approved medicine in the EU for IPF was pirfenidone (Esbriet, InterMune), indicated for only mild to moderate cases. Pirfenidone has been on the market in the EU since 2010. The FDA approved pirfenidone the same day it approved nintedanib. Both the FDA and the EMA previously had designated the two drugs as orphan products because of the relatively low number of people with IPF. Last year, the EMA said that IPF affects no more than three in 10,000 people in the EU, which is below the ceiling of five in 10,000 for orphan-status drugs there.

In justifying its decision on nintedanib, the CHMP cited two studies that looked at the rate of lung function decline, as measured by the absolute volume of forced vital capacity, or the amount of air that can be forcibly exhaled after a deep breath. The two studies reported that nintedanib reduced forced vital capacity decline by roughly 94 and 125 mL/year, respectively.

The drug comes in the form of a soft capsule in doses of 100 and 150 mg.

Gastrointestinal disorders, diarrhea, vomiting, and nausea are among the most common adverse effects of nintedanib.

The CHMP recommendation on nintedanib now goes to the European Commission, the EU's executive branch, for final approval. More information about this regulatory action is available on the EMA website.

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Cite this: Nintedanib (Ofev) Gets EMA Panel Backing for IPF - Medscape - Nov 24, 2014.

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