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IQWiG backs BMS' Yervoy for melanoma

Bucks trend of negative recommendations from German institute

IQWIG Germany

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) has given a robust endorsement to Bristol Myers Squibb's new melanoma treatment Yervoy, saying the drug provides "considerable added benefit" in the management of the disease.

Yervoy (ipilimumab) was approved last August in Europe for the second-line treatment of adult patients with advanced melanoma on the back of trials which showed it extended survival by almost four months when added to best supportive care.

"This prolongation of life provides an indication of major added benefit of ipilimumab," said the IQWiG, although it cautioned that BMS' drug also poses "major potential harm in the form of side effects".

The positive verdict comes on the heels of a string of disappointments for pharma companies trying to win approval for use of their drugs within Germany's national healthcare system.

Last week, IQWiG rejected GlaxoSmithKline's lupus treatment Benlysta (belimumab) on the grounds that there was a lack of evidence it was better than current standard therapy, while the agency also delivered a negative appraisal for Biogen Idec's multiple sclerosis drug Fampyra (prolonged-release fampridine).

Previously, Germany's approval system came in for strong criticism from Boehringer Ingelheim's chairman Andreas Barner after the company was unable to agree a price for its diabetes drug Trajenta (linagliptin).

 For BMS, the endorsement of Yervoy in Europe's biggest drug market is a boost as the drug is a growth driver at a time when the company is bracing itself for the loss of patent protection on mega-blockbuster Plavix (clopidogrel).

Worldwide sales of Yervoy reached $360m in 2011 as a whole, and continued to grow strongly in the first quarter of 2012, adding another $154m into BMS' coffers.

Analysts have predicted the drug could make $1bn to $2bn at peak, depending in part on the take-up of rival drug Zelboraf (vemurafenib) from Roche, which was approved last year for a subset of melanoma patients with the BRAF V600E genetic mutation.

11th May 2012

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