After almost 10 years on the market, the EMA is to withdraw its conditional approval of the Duchenne muscular dystrophy treatment Translarna (ataluren), after concluding there is still not enough evidence of its effectiveness.
Putting into jeopardy what was on track to be the first approved therapy in Europe for geographic atrophy (GA), an advanced form of age-related macular degeneration that causes blindness, Apellis Pharmaceuticals Inc. learned of a negative trend vote by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on its MAA for intravitreal pegcetacoplan.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Hipra Human Health SLU’s recombinant COVID-19 vaccine, Bimervax, as a booster in people ages 16 and older who have been vaccinated with an mRNA COVID-19 vaccine.
The first gene therapy to treat severe hemophilia A was among the drugs recommended for European approval by regulators from the EMA’s CHMP at its monthly meeting. Manufactured by Biomarin Pharmaceutical Inc., Roctavian (valoctocogene roxaparvovec) was recommended for conditional marketing authorization in the EU for severe hemophilia A in adults who do not have factor VIII inhibitors and no antibodies to adeno-associated virus serotype 5.
DUBLIN – The EMA has rejected Biogen Inc.’s application for European Union approval of Aduhelm (aducanumab), its controversial Alzheimer’s disease drug. Its human medicines committee (CHMP) issued a negative opinion on Biogen’s dossier during its December meeting this week, stating that the data from the key studies submitted in support of the application “were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease.”
DUBLIN – The European Medicines Agency’s human medicines committee, the CHMP, all but closed out the year by issuing positive opinions on eight marketing authorization applications during its December meeting. Its work for 2020 is not quite yet done, however. It has scheduled an extraordinary meeting for Dec. 29 to review an application from Pfizer Inc. and Biontech AG for their mRNA COVID-19 vaccine BNT162b2.
At its October meeting, the EMA’s Committee for Human Medicinal Products (CHMP) voted in favor of 11 new therapies, two of them for treating cancers and two for treating HIV-1. The European Commission will review the recommendations and make its decisions by the end of 2020.
DUBLIN – Emer Cooke, named this week as the next executive director of the EMA, is the first woman to lead the organization since its creation in 1994. She is due to take up the post in November, but her appointment must first be ratified by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). She is due to present a statement to the group on July 13.
DUBLIN – Johnson & Johnson’s Janssen Biotech arm is on the brink of a historic first vaccine approval, having secured a positive vote May 29 from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its prime-boost Ebola virus vaccine combo, Zabdeno (Ad26.Zebov) plus MVABEA (MVA-BN-Filo).
DUBLIN – Novartis AG, Bristol Myers Squibb Co. and Sanofi SA were among firms that secured positive opinions from EMA’s Committee for Medicinal Products for Human Use (CHMP) on marketing authorization applications for new therapies, which will progress to formal approvals 67 days from now. Because of the COVID-19 pandemic, the committee’s March meeting was held virtually.