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EU agency recommends 66 drugs in 2019, lowest in 5 years

The European Medicines Agency recommended 66 medicines for marketing authorization in 2019, its lowest number of recommendations in five years, data compiled by S&P Global Market Intelligence showed.

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2019 was marked by several "firsts," such as when the EMA's Committee for Medicinal Products for Human Use, or CHMP, recommended the approval of Merck & Co. Inc.'s Ebola vaccine Ervebo to protect at-risk adults against the deadly virus — a decision hailed by the World Health Organization as a "triumph for public health."

Another first-of-its-kind therapy to receive the agency's backing was Portola Pharmaceuticals Inc.'s Ondexxya, an antidote for patients taking blood-thinning medicines apixaban or rivaroxaban — prescribed to those with heart disease or diabetes.

After a win in the U.S., GW Pharmaceuticals PLC's marijuana-based epilepsy treatment Epidyolex was also recommended for marketing authorization by the CHMP.

The European Commission needs to give a final sign-off on the CHMP's recommendations before treatments can hit the market.

The CHMP backed the approval of five biosimilars in 2019, including three for AbbVie Inc.'s top-selling rheumatoid arthritis drug Humira, or adalimumab. These biosimilars were Fresenius SE & Co. KGaA's Idacio and Kromeya, and Pfizer's Amsparity.

Two other biosimilars that made the cut in 2019 were Juta Pharma GmbH's Grasustek and Mundipharma Biologics S.L.'s Pegfilgrastim Mundipharma, both for Amgen Inc.'s blockbuster medicine Neulasta, or pegfilgrastim, which is used to promote the production of new white blood cells.

Biosimilars are biological products that act in the same way as their existing regulatory-approved reference products. They are intended to be lower-cost versions of biologic therapies.

New therapies addressing orphan diseases were also granted positive opinion by the CHMP: Akcea Therapeutics Inc. and Ionis Pharmaceuticals Inc.'s Waylivra as the first medicine for familial chylomicronemia syndrome, or FCS, a rare genetic disease that prevents the body from breaking down a type of fat called triglycerides; BioMarin Pharmaceutical Inc.'s Palynziq for treating patients with phenylketonuria — a rare metabolic disease characterized by intellectual disability, seizures and behavioral problems; and bluebird bio Inc.'s Zynteglo, a gene therapy for beta-thalassaemia, a rare inherited blood condition that causes severe anemia.

During the year, new and additional diabetes drugs won the EMA's recommendation, such as AstraZeneca PLC's oral medicines Forxiga and its duplicate Edistride for type 1 diabetes patients who are taking insulin; Sanofi's Zynquista, also an oral medicine, for overweight adults with type 1 diabetes whose condition is not adequately controlled by insulin alone; and Novo Nordisk A/S' Victoza for children and adolescents aged 10 years or older with type 2 diabetes.

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Ranitidine review

The EU regulator found itself reviewing another medicine for the possible presence of the impurity N-nitrosodimethylamine, or NDMA, in 2019. High levels of NDMA could potentially cause cancer in humans.

EMA said in September that it was conducting a review of ranitidine medicines after tests detected traces of NDMA in the pharmaceutical products.

Ranitidine drugs, which are marketed by French pharmaceutical giant Sanofi as Zantac, among others, are used to treat stomach ulcers. Companies including Sanofi, GlaxoSmithKline PLC, Novartis AG, Teva Pharmaceutical Industries Ltd. and Mylan NV recalled their branded and generic versions of the stomach medicine while the regulatory reviews are ongoing.

Previously, some blood pressure medicines known as sartans were found to contain NDMA, prompting the EMA to start investigations into the origin of the contamination for those class of medicines.