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Boehringer's Ofev approved by FDA for rare lung disease

US regulator also gives the green light to Intermune's Esbriet
FDA Headquarters White Oak

The US FDA has approved its first two drugs for the treatment of the rare lung disease idiopathic pulmonary fibrosis (IPF).

One of the drugs - nintedanib - is already marketed by Boehringer Ingelheim as a lung cancer treatment under the name Vargatef, but it has also demonstrated an effectiveness in treating IPF, a disease where the lungs become progressively scarred over time.

Boehringer will market nintedanib as Ofev in this indication, with the oral drug to be taken twice-daily.

The other drug approved by the FDA for IPF is Esbriet (pirfenidone), which is marketed by Intermune

The approvals are significant because IPF patients in the US previously had no medicinal alternative to oxygen therapy, pulmonary rehabilitation and lung transplant to treat the condition.

The lack of treatments in the area meant that both Ofev and Esbriet received multiple breaks from the FDA to accelerate their review process, include fast track, priority review, orphan product and breakthrough designations.

With the benefit of these labels Ofev was approved well ahead of its goal date of January 2, 2015, while the approval for Esbriet comes five weeks ahead of schedule.

It's unclear what the uptake of either product, each of which works in a different way, will be.

Ofev is a small molecule tyrosine kinase inhibitor (TKI) that targets several growth factors involved in IPF: the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and the platelet-derived growth factor receptor (PDGFR).

Esbriet worked by blocking the synthesis of TGF-beta, a chemical that controls many cell functions and plays a key role in fibrosis.

Dr Badrul Chowdhury, director of the FDA's division of pulmonary, allergy and rheumatology products, said: “Neither drug is a cure. IPF may still progress after patients use these drugs. However, each drug has been shown to significantly slow the progression of the disease.”

Esbriet was approved in the EU in 2011 while nintedanib is currently under review as a treatment for IPF in the region.

17th October 2014

From: Sales

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