FDA green lights Lemtrada for MS
pharmafile | November 17, 2014 | News story | Sales and Marketing |Â Â FDA, Genzyme, Lemtrada, MS, Sanofi, rems, tecfideraÂ
The US FDA has approved Sanofi’s Lemtrada for multiple sclerosis, almost a year after rejecting the drug on concerns about its safety profile.
Last December, the US regulator said Sanofi’s Genzyme subsidiary had not been able to demonstrate that the benefits of Lemtrada (alemtuzumab) outweighed its side effects, despite the fact that the drug had already been approved for marketing in Europe.
The FDA has cleared Lemtrada for the treatment of patients with relapsing forms of MS, but only if they have tried and failed treatment with two other approved drug therapies, and via a restricted distribution system through “certified prescribers, healthcare facilities and specialty pharmacies”.
Genzyme’s chief executive David Meeker said the risk evaluation and mitigation strategy (REMS) has been implemented to “help detect and manage the serious risks identified with treatment”.
The product will carry a boxed warning about the risks of serious and sometimes fatal autoimmune conditions and infusion reactions and also noting that Lemtrada is associated with an increased risk of cancer.
Approval of Lemtrada was based on the results of the CARE-MS I trial, which showed the drug was significantly more effective than Biogen Idec’s Rebif (interferon beta-1a) in reducing annualised relapse rates in MS patients, with a trend towards slower disease progression.
The anti-CD52 antibody was sold for many years at a higher dose as Campath – used to treat various forms of leukaemia – although this product was withdrawn from the market around the time Lemtrada was launched. As an MS therapy it is dosed just twice a year by intravenous infusion.
Ahead of the FDA rejection last year, Lemtrada had been predicted by analysts to make around $700 million in sales by 2018.
The US knock-back clearly affected that target, although the drug has been making slow progress in its approved markets too, which now number 40 worldwide. In the first nine months of the year it brought in just €18 million, and Sanofi and Genzyme will be hoping FDA approval will boost sales momentum.
The market for MS therapies is becoming increasingly competitive however, with new oral treatments such as Novartis’s Bioen Idec’s Tecfidera (dimethyl fumarate), Gilenya (fingolimod) and Sanofi’s own Aubagio (teriflumonide) – starting to eat into the market share of older injectable drugs such as Rebif and Teva’s Copaxone (glatiramer acetate).
Phil Taylor
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