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Ipsen Buoyant Despite EMA’s Bylvay Orphan Status Block

 
• By Kevin Grogan

The French company plans to refile Bylvay for Alagille syndrome under a new brand name after the EMA's Committee for Orphan Medicinal Products said the drug did not meet its 'significant benefit' criteria.

Ipsen wrexham
• Source: Ipsen

Ipsen SA has posted a reasonable set of third quarter financials, including the first sales of its recently approved ultra-rare disorder drug Sohonos, but growth plans for its bile acid modulator, Bylvay, have hit a huge stumbling block in Europe.

Revenues in the third quarter dipped by 0.3% excluding currency impact to €772.4m, with sales of the somatostatin analog Somatuline (lanreotide) for acromegaly and neuroendocrine tumors, Ipsen’s biggest earner, falling by 16.9% to €265.5m

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