Novo’s Ozempic among Europe’s drug recommendations
Alongside the recommendation for what is set to be the first ever allogeneic stem cell therapy from TiGenix and Takeda, a number of other notable drugs got a European thumbs up on Friday.
The CHMP committee recommended a rare disease drug from Kyowa Kirin, its Crysvita backed for use in the bone disease X-linked hypophosphataemia (XLH).
It recommended conditional marketing authorisation for the orphan drug in the disease, where there is radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons.
Other notable CHMP decisions included Novo Nordisk’s Ozempic (semaglutide) weekly diabetes injection – a potential blockbuster that has recently gained full FDA approval.
The glucagon-like peptide 1 (GLP-1) receptor agonist has a once-weekly dosing, and Novo hope its superior efficacy can help it dominate the market and beat off competition from the likes of Lilly’s Trulicity.
And Roche’s big-selling breast cancer drug, Herceptin (trastuzumab) faces another cheaper biosimilar competitor in Europe.
Celltrion’s Herzuma got backing from the CHMP – a month after fellow South Korean firm Samsung Bioepis got its drug through the committee.
There was also one rejection: the CHMP adopted a negative opinion for PharmaMar’s Aplidin (plitidepsin) as a treatment of multiple myeloma.
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