Boehringer gains EU approval for Ofev
The European Commission has approved Boehringer Ingelheim’s Ofev as a treatment for idiopathic pulmonary fibrosis (IPF).
The approval follows the EMA’s Committee for Medicinal Products for Human Use (CHMP) giving the drug a positive opinion in November last year, following an expedited EMA review.
Ofev (nintedanib) is only the second treatment available in IPF. Its big rival, Roche’s Esbriet (pirfenidone), was first to market in Europe in three years ago. Neither treatments can cure the disease, only slow its progression.
Ofev is already available in the US having been approved by the FDA in October. However, Esbriet that was originally developed by InterMune, who were acquired by Roche in September – has been available in Europe since 2011 when it became the first IPF treatment available in the world.
Esbriet took longer to make it to market in the US, however, and was in fact approved by the FDA on the same day as Ofev. The nod from the EC means the two drugs will continue to go head-to-head in both markets.
Professor Klaus Dugi who is the chief medical officer at Boehringer Ingelheim, says: “Approval of this treatment for patients in the EU is a significant step towards meeting the substantial unmet need in IPF. Patients suffering from this chronic, debilitating disease can now be offered a new treatment option that has been shown to have a clinically meaningful effect on their disease.”
Professor Luca Richeldi from the University of Southampton who took part in Ofev’s clinical trials, adds: “Until recently, treatment options for patients with IPF were limited. The approval of Ofev in the EU gives patients with a life threatening illness a choice of therapy with proven efficacy.”
And Dr Toby Maher, a consultant respiratory physician at the Royal Brompton Hospital in London says: “It’s great that there is now a choice of treatments for IPF patients. This approval provides important hope for patients and caregivers living with this awful disease.”
In Phase III trials of more than 1,000 people, Ofev slowed the progression of IPF (a lung disease that causes lung scarring and damage and has a poor median survival), slowed down lung damage and reduced the frequency of flare-ups. Worldwide IPF affects between 14 and 43 people per 100,000, most commonly people over the age of 50.
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