EMA Recommends New HCV, Cancer and MS Drugs for Approval

Regulatory NewsRegulatory News | 23 June 2017 |  By 

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended eight new medicines for approval, including two pan-genotypic hepatitis C (HCV) drugs and a third biosimilar for AbbVie's Humira (adalimumab).

EMA says that both HCV drugs, AbbVie's Maviret (glecaprevir/pibrentasvir) and Gilead's Vosevi (sofosbuvir/velpatasvir/voxilaprevir), were given a speedy review under the agency's accelerated assessment mechanism.

Both drugs are currently being reviewed by the US Food and Drug Administration. In February, AbbVie announced that its glecaprevir/pibrentasvir combination was granted a priority review by the agency, and Reuters is reporting that a decision is expected for Gilead's combination by 8 August 2017.

EMA also recommended Samsung Bioepis' Humira biosimilar candidate Imraldi, which will be commercialized in the EU by Biogen. The announcement comes just five months after the agency recommended two Humira biosimilars developed by Amgen.

In addition, EMA recommended two cancer medicines, Novartis' breast cancer drug Kisqali (ribociclib) and EUSA Pharma's renal cell carcinoma drug Fotivda (tivozanib), and German Merck's multiple sclerosis drug Mavenclad (cladribine). The agency also recommended Mylan's generic version of Bristol-Myers Squibb and Gilead's HIV drug Atripla (efavirenz/emtricitabine/tenofovir) and MendeliKABS' generic version of Swedish Orphan Biovitrum International's Orfadin (nitisinone).

Symbioflor 2

EMA also updated on its Article 31 review of Symbioflor 2, a probiotic drug containing Escherichia coli (E.coli) that is currently authorized in Germany, Hungary and Austria and has been used to treat irritable bowel syndrome (IBS) and other functional gastrointestinal disorders since the 1950s.

The review was requested by the German regulator BfArM out of concern that the drug's effectiveness had not been adequately proven.

According to EMA, Symbioflor 2 can still be used to treat IBS in adults, but should not be used to treat other gastrointestinal disorders. However, the agency says the evidence supporting Symbioflor 2 has "weaknesses" and the drug has not been proven effective in children.

The agency also says it has requested the product's manufacturer, SymbioPharm GmbH to conduct a "well-designed" study on the drug in across patients with different IBS symptoms as a condition for maintaining marketing authorization.



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