Biogen gets CHMP thumbs up
pharmafile | May 27, 2014 | News story | Sales and Marketing | Biogen, CHMP, Gazyvaro (obinutuzumab), Nuwiq, Octapharma, Orphan, Roche, chronic lymphocytic leukaemia, plegridy
Biogen Idec is celebrating after the Committee for Medicinal Products for Human Use (CHMP) gave its multiple sclerosis drug Plegridy the thumbs up.
It was one of six medicines given a positive opinion at the CHMP meeting last week, with the European Commission expected to rubberstamp the European Medicines Agency advisory body’s decisions in the next few months.
The recommendations included Gazyvaro (obinutuzumab), Roche’s orphan drug for the treatment of chronic lymphocytic leukaemia, and Octapharma’s Nuwiq (simoctogog alfa) to stop bleeding in patients with haemophilia A.
The CHMP believes Plegridy (peginterferon beta-1a), an investigational subcutaneous injection, should be used in adults with relapsing remitting multiple sclerosis in adults and Biogen called it an ‘important milestone’.
“We believe peginterferon beta-1a will offer physicians and those living with MS a unique treatment option that combines efficacy, a favourable safety profile consistent with the established interferon class and a once-every-two-week dosing schedule,” says Douglas Williams, Biogen’s executive vice president of R&D.
The decision was primarily based on Phase III data from the ADVANCE trial, which took in more than 1,500 MS patients and showed that annualised relapse rate at one year was cut by 36% compared to placebo.
The drug ‘significantly reduced’ new or newly-enlarging T2-hyperintense lesions versus placebo too.
Elsewhere, the committee also turned round an earlier negative decision by suggesting PTC Therapeutics’ Translarna (ataluren), an orphan-designated medicine for genetic disease Duchenne muscular dystrophy, should now receive conditional marketing authorisation.
The life-threatening condition gradually causes weakness and loss of muscle function: Translarna would be used in patients aged five years and older who are able to walk.
PTC asked the CHMP to reconsider its ‘no’ verdict and the committee undertook “a re-analysis of the clinical data submitted by the company” before making its U-turn.
The manufacturer, which is classified as a small or medium-sized enterprise (SME), will have to provide ‘comprehensive’ data from an ongoing study – but the conditional decision is part of an early access mechanism for unmet medical needs.
Other recommendations by the CHMP included Alcon’s Simbrinza (brinzolamide/brimonidine tartrate) to treat open-angle glaucoma or ocular hypertension and Chiesi’s Envarsus (tacrolimus), to prevent transplant/allograft rejection.
The CHMP also suggested extending indications for GlaxoSmithKline’s Arzerra, Eisai’s Halaven and Pfizer’s Vfend.
Adam Hill
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