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AstraZeneca's Imfinzi, 15 other new drugs recommended for EU approval

The European Medicines Agency recommended the approval of 16 new therapies this month, including AstraZeneca PLC's Imfinzi and Eli Lilly and Co.'s Verzenios.

Imfinzi is indicated for use in treating non-small cell lung cancer, or NSCLC. Verzenios is used for treating locally advanced or breast cancer that has spread to other parts of the body.

The agency's Committee for Medicinal Products for Human Use granted a positive opinion to Alnylam Pharmaceuticals Inc.'s Onpattro, indicated for treating hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.

Hereditary transthyretin-mediated amyloidosis, or hATTR amyloidosis, is a rare, genetic, progressive disease that causes the formation of a type of protein called amyloid fibrils in the nerves, heart or gastrointestinal tract. Polyneuropathy is the condition where hATTR amyloidosis affects the peripheral nervous system, damaging the nerves and leading to improper function.

The EMA also recommended the approval of Pierre Fabre Medicament SA's cancer drug combination, Braftovi and Mektovi, to treat adult patients with melanoma positive with BRAF V600 mutation that has spread or cannot be removed through surgery.

The panel recommended granting pediatric-use marketing authorizations for Kigabeq, Orphelia Pharma SA's hybrid medicine for treating infantile spasms or West syndrome, and Slenyto, a drug from RAD Neurim Pharmaceuticals EEC Ltd. indicated to treat insomnia in children and adolescents with autism spectrum disorder or Smith-Magenis syndrome, a developmental disorder that affects many parts of the body.

The committee also backed the approval of three biosimilars: Mylan NV's Hulio, a biosimilar of AbbVie Inc.'s blockbuster drug Humira, to treat certain inflammatory and autoimmune disorders, and Accord Healthcare Ltd.'s Pelgraz and ERA Consulting GmbH's Udenyca — both biosimilars to Amgen Inc.'s Neulasta which is indicated for use in reducing the duration of neutropenia, or the lack of a type of white blood cells called neutrophils, and the incidence of febrile neutropenia due to chemotherapy.

The panel also recommended approving Ilumetri from Spanish drugmaker Almirall SA to treat moderate to severe plaque psoriasis.

The committee did the same for Vertex Pharmaceuticals Inc.'s Symkevi to treat cystic fibrosis, a genetic disorder that affects mostly the lungs, but also the pancreas, liver, kidneys and intestine.

Xerava, Tetraphase Pharmaceuticals Inc.'s antibacterial drug, also won the CHMP's positive opinion for treating complicated intra-abdominal infections in adults.

Three generic therapies were also recommended for approval: Lipomed AG's deferiprone, a generic version of Apotex Inc.'s Ferriprox, for treating iron overload in patients with thalassaemia major, an inherited blood disorder characterized by abnormal hemoglobin production; Mylan's gefitinib, a generic copy of AstraZeneca's lung cancer drug Iressa; and Accord Healthcare's lenalidomide, a generic version of Revlimid, Celgene Corp.'s multiple myeloma medicine.

Meanwhile, after re-examination, the committee issued negative opinions for Portola Pharmaceuticals Inc.'s Dexxience, a drug intended to prevent blood clots from forming in the deep veins of the leg, and Radius International Inc.'s osteoporosis treatment, Eladynos.

Elsewhere, Bristol-Myers Squibb Co. withdrew its application to extend Opdivo's use in treating patients at high risk of kidney cancer returning after surgery. FGK Representative Service GmbH's application for Raligize to treat cervical cancer was also withdrawn.