The highlight of the latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use is a recommendation that InterMune's idiopathic pulmonary fibrosis treatment Esbriet should be approved.
The CHMP has adopted a positive opinion on Esbriet (pirfenidone) for the treatment of mild to moderate IPF. The recommendation follows a speedy review, which only began at the end of March and if the green light is given in the next two to three months, it will be the first drug in Europe to be approved for the debilitating and fatal lung disease.
Esbriet is already marketed in Japan as Pirespa by Shionogi but it has found the US approval pathway to be trickier. In May, the Food and Drug Administration rejected pirfenidone the drug despite its Pulmonary-Allergy Drugs Advisory Committee voting 9-3 to recommend approval in March.
InterMune shares leapt 144.5% on the positive opinion in Europe, where some analysts believe Esbriet could garner sales of over $1 billion. More than 100,000 Europeans who suffer from IPF and the company's chief executive Dan Welch said "we are now focusing our efforts on completing our commercial launch preparations".
Back to the CHMP meeting and positive opinions were adopted for Orphacol (cholic acid), from Laboratoires CTRS, intended for the treatment of inborn errors in primary bile acid synthesis and Teysuno (tegafur/gimeracil/oteracil), Taiho Pharma's treatment of advanced gastric cancer in adults given in combination with cisplatin. There were also recommendations for Johnson & Johnson's Xeplion (paliperidone) for schizophrenia and Pfizer's Xiapex (collagenase clostridium histolyticum) for Dupuytren’s contracture.
The committee has also recommended the granting of marketing authorisations for three generics - Krka's version of Sanofi-Aventis' Sanofi’s antihypertensive CoAprovel (irbesartan/hydrochlorothiazide), plus two Teva copies of Sanofi's rheumatoid arthritis drug Arava (leflunomide).
The CHMP has also recommended that Ranbaxy's version of Roche's acne drug Roaccutane (isotretinoin) should not be granted approval in many European states and be suspended in the UK, where it is already authorised. This comes after a procedure was initiated because of concerns that bioequivalence to the reference product had only been shown under fasting, but not under fed, conditions, and that this could thus result in suboptimal dosing.
The committee concluded that bioequivalence has not been shown accordingto current requirements, and that the benefit-risk balance of Ranbaxy'sversion is negative.