CHMP recommends Jardiance
pharmafile | March 24, 2014 | News story | Research and Development, Sales and Marketing | Boehringer, CHMP, EU, diabetes, jardiance, lilly
Boehringer Ingelheim and Eli Lilly’s type 2 diabetes treatment Jardiance is among nine medicines which the Committee for Medicinal Products for Human Use (CHMP) recommended for approval at its most recent meeting.
“The CHMP positive opinion brings us a step closer to having a potential new treatment option in Europe for people with type 2 diabetes,” said Klaus Dugi, Boehringer’s corporate senior vice president medicine.
The European Commission usually rubber-stamps the CHMP view, granting marketing authorisation about two months afterwards – and if this proves to be the case, Jardiance (empagliflozin) would be the third product approved in Europe as part of Boehringer and Lilly’s diabetes alliance.
The eight other medicines receiving the CHMP nod include Endocyte and MSD’s orphan drug Vynfinit (vintafolide) for women with a sub-type of platinum-resistant ovarian cancer, for which there are currently limited approved treatment options.
The manufacturers have just released positive mid-stage trial results for vintafolide in lung cancer, the Phase 2b TARGET study showing that the drug, in combination with chemotherapy agent docetaxel, reduced the risk of the disease worsening, or death by 25% compared with using docetaxel alone.
CHMP approval has also been given to a pair of companion diagnostics, Folcepri (etarfolatide) and Neocepri (folic acid), to identify patients who may benefit from Vynfinit in ovarian cancer – the CHMP thinks all three should have conditional marketing authorisations.
Janssen has two drugs on the CHMP list: orphan-designated Sylvant (siltuximab) is there after an accelerated assessment for the treatment of adult patients with multi-centric Castleman’s disease, plus Olysio (simeprevir) for chronic hepatitis C in adults.
There are also positive opinions for Takeda’s ulcerative colitis and Crohn’s disease medicine Entyvio (vedolizumab) and GlaxoSmithKline’s Revinty Ellipta (fluticasone furoate /vilanterol trifenatate) for sufferers from asthma and chronic obstructive pulmonary disease (COPD).
Actavis’ generic version of Tamiflu, Ebilfumin (oseltamivir), has also been given the nod.
Adam Hill
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