Patients in Europe are soon to get access to Biogen Idec’s Tecfidera after the continent’s regulators finally gave the green light to the eagerly-watched multiple sclerosis pill.
The drug has been a stellar performer in the USA since its approval in March last year and Biogen reported Tecfidera (dimethyl fumarate) sales of $397.6 million for the fourth quarter. The pill was recommended for approval by the European Medicines Agency’s Committee for Human Medicinal Products in November, after the company received assurances regarding patent protection.
In an interview with PharmaTimes, David Allsop, head of commercial operations in Europe, noted that Biogen launched its first MS product, Avonex (interferon beta-1a), 17 years ago and even though doctors were delighted to actually get a drug, “they were unimpressed it was an injectable so to have an oral on the market with this level of efficacy is very, very exciting”.
He noted that Tecfidera will now be available in Germany “in the next couple of days” and then in other countries which have reasonably quick reimbursement of three or four months; the Scandinavian countries will probably be next, after Germany. As for the UK, Biogen is in the middle of the process of talking to the National Institute for Health and Care Excellence and the official approval will drive that on.
Mr Allsop is very confident the launch will be a successful one. “We have been in MS for so long all of our sales forces understand the disease…they know the data and understand the needs of the patient so they are chomping at the bit”. As well as Avonex, Biogen also markets Tysabri (natalizumab).
NICE backed Sanofi’s MS pill Aubagio (teriflunomide) in January and he told PT “we are happy that anyone gets through and the more products out there the better for patients. The disease is so heterogenous, I think there is enough room out there for all of us”. He concluded by saying that as well as its marketed products, “we have a very deep pipeline in MS”.
News of the approval went down well with the UK’s MS Society and Nick Rijke, its director for policy and research, told PT that Tecfidera “offers a step forward in efficacy as well as the ease of using tablets”. However, he added that “the only way this treatment will really make a difference for the majority of people with MS is if it’s approved for use by the NHS, and we eagerly await that decision over the coming months”.
