Eisai gets EMA nod for Lenvima just weeks after FDA approval

Eisai has gotten its second dose of good news in as many months. Weeks after getting an FDA approval for its thyroid cancer drug Lenvima, the struggling Japanese drugmaker has gotten the nod for the potential blockbuster by the European Medicines Agency (EMA).

The EMA today recommended approval of Lenvima for patients with progressive, differentiated thyroid cancer (DTC). The drug is designated by the EMA as an orphan drug. The FDA approved the drug in February, two months ahead of schedule, also for DTC, the most prevalent form of thyroid cancer and one that kills nearly 2,000 Americans each year. The FDA also received orphan product designation because it is intended to treat the rare disease.

Lenvima will compete with Bayer's cancer-fighter Nexavar, which won approval in 2013 for treating thyroid cancer, but Eisai is also hoping to win approval for the drug for treating other cancers such as liver, kidney, lung and endometrial cancers. If it gets those approvals, an Eisai exec has said the drugmaker believes Lenvima can hit $1 billion in annual sales by 2020, although that is more than double a forecast from Evaluate Pharma, which pegs its sales at $424 million by 2019.

The drugmaker can use a sales boost after losing patent protection for its Alzheimer's drug Aricept and its acid reflux treatment AcipHex. The company's latest launches, weight-loss drug Belviq and seizure med Fycompa, have also faced their fair share of problems.

Eisai ramped up its sales force and expanded its DTC campaign for Belviq last year to try to boost sales. But Belviq, as well as obesity drug Qsymia from Vivus ($VVUS), both early to the market, are seeing competition from new products, Novo Nordisk's ($NVO) Saxenda and Contrave from Orexigen Therapeutics' ($OREX). Analysts have suggested that those sales of those two drugs could eclipse their forerunners. The EMA today recommended Orexigen's Mysimba, as it is named in Europe, for treating obesity.

- here's the EMA announcement

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