Sanofi’s Lemtrada nears EU approval
pharmafile | July 1, 2013 | News story | Sales and Marketing | CHMP, Genzyme, Lemtrada, Sanofi
Sanofi’s multiple sclerosis drug Lemtrada has received a positive recommendation from the CHMP, meaning a European approval is likely just months away.
The CHMP, which advises the European Medicines Agency, has recommended Lemtrada (alemtuzumab) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease, defined by clinical or imaging features.
David Meeker, Genzyme’s president and chief executive, said: “The CHMP opinions set the stage for the approval of two important new treatment options for MS patients. Treatments to-date have addressed some of the unmet needs in MS, but still have limitations.
“Upon approval, physicians will have the ability to prescribe Lemtrada for appropriate relapsing remitting patients based on their impressions of clinical or imaging characteristics regardless of duration of disease or treatment history.”
Meeker added that hopes for the drug among the MS community were high, saying that with the CHMP opinion: “We are a step closer to making this very innovative treatment available for MS patients in Europe.”
The drug, developed by Genzyme – now a subsidiary of Sanofi – is also being co-promoted with Bayer, meaning the German firm will receive payments based on sales revenue.
Lemtrada was pivotal in Sanofi securing its 2010 merger with Genzyme, and is set to compete with Novartis’s MS pill Gilenya, as well as older injectable drugs such as Merck Serono’s Rebif and Biogen’s Tysabri.
In March the CHMP also gave a recommendation for Biogen’s MS drug Tecfidera, and Genzyme’s other MS treatment Aubagio, meaning it is relatively late to market.
Analysts have been split on Lemtrada’s earning potential, but most see the medicine as a future blockbuster, especially after forecasts for Gilenya were cut due to safety concerns.
Eric Le Berrigaud, an analyst at Bryan, Garnier, told Reuters: “In Europe, there’s little doubt it will be kept for fairly advanced stages of MS and I would expect it to be positioned similar to Tysabri.”
Lemtrada has not had an easy ride and after several decades of clinical trials, the drug is now finally on its way for approval in MS.
The reason it has taken so long is because the drug has changed hands so many times in the last 15 years, starting originally at Wellcome – now GlaxoSmithKline in the 1990s.
Multiple sclerosis affects around 2.5 million people worldwide and is a chronic, often disabling disease that attacks the central nervous system, which is made up of the brain, spinal cord and optic nerves.
Symptoms may be mild or severe, ranging from numbness in the limbs to paralysis or loss of vision. The progression, severity, and specific symptoms of MS are unpredictable and vary from one person to another.
Ben Adams
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