Sanofi's hard-hit Lemtrada goes under EU review for fatal side effects in heart, blood vessels

After a tough year in the competitive multiple sclerosis field, Sanofi’s Lemtrada could hardly afford another setback. But that’s exactly what it received last week.

On Friday, the European Medicines Agency (EMA) recommended temporary restriction of Lemtrada’s use as the agency reviews reports that the drug compromises patients’ immune systems and potentially leads to fatal side effects in the heart and blood vessels.

In its recommendation, the agency’s Pharmacovigilance Risk Assessment Committee said use of the intravenous drug should be limited only to relapsing-remitting MS that is highly active despite treatment with at least two disease-modifying therapies or where other DMTs cannot be used. In addition, the agency is weighing placing new safety warnings on Lemtrada’s label.

Once the EMA’s review is complete, the final findings will be submitted to the Committee for Medicinal Products for Human Use before a final decision is made by the European Commission. Lemtrada received EU approval in 2013.

RELATED: FDA hits Sanofi's struggling Lemtrada with new safety warning over reports of stroke, artery tears

The hurdle in Europe comes after a troubled year in which Lemtrada was flagged by the FDA for upping the risk of artery tears and stroke, and more challengers entered the packed MS market.

In November 2018, the FDA issued a safety warning for Lemtrada after reports of “rare but serious” cases of stroke and tears in the lining of head and neck arteries cropped up among Lemtrada patients shortly after receiving the drug. The FDA said 13 patients had reported such cases after the drug’s U.S. approval in 2014.

As part of its notice, U.S. regulators altered the drug’s prescribing label medication guide and existing black-box warning to reflect the reported health risks.

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In late March, Merck KGaA’s Mavenclad received a long-delayed FDA approval, adding more pressure to Lemtrada’s flagging sales in a crowded field that includes Novartis’ Gilenya and Mayzent, Biogen’s Tecfidera and Tysabri along with Roche’s Ocrevus. In addition, Celgene recently resubmitted its FDA approval request for ozanimod, a treatment for relapsing MS.

And as competition and regulatory scrutiny have increased, Lemtrada’s sales have fallen. In fiscal 2018, Sanofi reported sales of the drug sank 15% from 2017 to land at €402 million euros ($454.6 million).

RELATED: Can Sanofi's new long-term Lemtrada data amp up sales in a crowded MS field?

That poor showing followed a 2017 in which Lemtrada’s sales increased, but not up to analyst expectations. Sanofi has had to fend off the decline of its aging diabetes division and has leaned on its MS offerings in recent years.

Sanofi is hoping positive data from an eight-year clinical trial will help Lemtrada stay afloat in the market. Last October, the company rolled out phase 3 clinical data showing Lemtrada was still working in about half of relapsing-remitting MS patients eight years after their initial two treatment courses.