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Merck & Co.'s Ebola vaccine, 6 others backed for EU approval


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Merck & Co.'s Ebola vaccine, 6 others backed for EU approval

The European Medicines Agency recommended the approval of seven new therapies in October, including Merck & Co. Inc.'s Ebola vaccine Ervebo.

Ervebo, or rVSVΔG-ZEBOV-GP, live, is intended for active immunization in individuals aged 18 years or older at risk of infection with the Zaire Ebola virus.

If granted marketing authorization by the European Commission, Ervebo will be the first vaccine approved in Europe to protect against Ebola. The World Health Organization hailed the EMA's decision as a "triumph for public health."

"This vaccine has already saved many lives in the current Ebola outbreak, and the decision by European regulator will help it to eventually save many more," WHO Director-General Tedros Adhanom said in a statement.

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The European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, also gave a positive opinion on Eli Lilly and Co.'s Baqsimi to treat severe hypoglycemia in diabetes patients age four years and older. Baqsimi, or glucagon, is the first low blood sugar therapy that can be administered through the nose using a single-use dispenser.

The CHMP also backed the approval of Quofenix, A. Menarini Industrie Farmaceutiche Riunite Srl's drug for acute bacterial skin and skin structure infections in adults when it is considered inappropriate to use other antibacterial agents.

The EMA also granted positive opinions to AbbVie Inc.'s rheumatoid arthritis medicine Rinvoq and Johnson & Johnson's Spravato, an esketamine nasal spray for adults with treatment-resistant major depressive disorder.

Also receiving the CHMP's backing was Pegfilgrastim Mundipharma, a biosimilar medicine developed by Mundipharma Biologics S.L. to reduce the duration of neutropenia — a condition characterized by an abnormally low concentration of a white blood cell known as neutrophils — and the incidence of febrile neutropenia due to chemotherapy, or fever associated with neutropenia.

The panel also recommended approving Amgen Inc. and UCB SA's osteoporosis drug Evenity after a reexamination.

Evenity, or romosozumab, is a potential treatment for severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke.

The Amgen-UCB bone drug was initially given a negative opinion by the CHMP, citing safety concerns.

Meanwhile, the committee issued a negative opinion for D&A Pharma SAS' Hopveus, an intended treatment of alcohol dependence in adults. CHMP said it was unable to confirm the drug's effectiveness.

Daiichi Sankyo Co. Ltd.'s blood cancer drug Vanflyta also received a negative recommendation from the EMA panel, noting that its benefits did not outweigh the risks. The Japanese company developed Vanflyta, or quizartinib, for adults with acute myeloid leukemia, a type of cancer affecting the white blood cells.

Four medicines were backed by the regulator for extended indications, including Genmab A/S' Darzalex combined with cancer drug lenalidomide and corticosteroid medicine dexamethasone for newly diagnosed adult patients with multiple myeloma who are ineligible for autologous stem cell transplant.

Vertex Pharmaceuticals Inc.'s Kalydeco for cystic fibrosis — a genetic disorder that affects the lungs, digestive system and other organs — and Merck & Co.'s Keytruda as an initial treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma, were also backed for extended approvals.

Additionally, Keytruda was recommended for extended approval as a single therapy or in combination with platinum and 5-fluorouracil chemotherapy for patients whose tumors express the PD-L1 protein.

The CHMP recommended the broader use of Sanofi's Toujeo to control the blood sugar levels of adults with diabetes who need insulin.

However, the EMA committee refused to extend the indication of Novartis AG's anemia drug Revolade and PTC Therapeutics Inc.'s Duchenne muscular dystrophy drug Translarna even after a reexamination of the companies' applications.

Elsewhere, Sun Pharmaceutical Industries Ltd. withdrew its application for Ekesivy, a drug intended to treat periodic paralysis. Paratek Pharmaceuticals Inc. did the same for its application for Nuzyra to treat community-acquired bacterial pneumonia and bacterial infections of the skin and skin structures.

Emmaus Life Sciences Inc.'s marketing application for its sickle cell treatment Xyndari was also withdrawn. The regulator said in May that the medication was not effective and adopted a negative opinion.