EMA Recommends Sixteen Medicines for Approval

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The recommended drugs include two orphan medicines and three biosimilars.

The European Medicines Agency (EMA) announced on July 27, 2018 that its Committee for Medicinal Products for Human Use (CHMP) recommended 16 medicines for approval during its July 2018 meeting. The recommended drugs include treatments for cancer, hereditary transthyretin-mediated amyloidosis, cystic fibrosis, autoimmune disorders, and an antibacterial.

Orphan drug Onpattro (patisiran) was approved for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy. EMA reviewed the drug through its accelerated assessment procedure. A second orphan drug, Symkevi (tezacaftor/ivacaftor), was given a positive opinion for the treatment of cystic fibrosis.

CHMP gave positive opinions for three biosimilars. Hulio (adalimumab) was given a positive opinion for the treatment of certain inflammatory and autoimmune disorders. Pelgraz (pegfilgrastim) and Udenyca (pegfilgrastim) were approved for reducing the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.

Marketing authorization was also recommended for generic drugs Deferiprone Lipomed (deferiprone), for the treatment of iron overload in patients with thalassaemia major; Gefitinib Mylan (gefitinib), for the treatment of non-small cell lung cancer; and Lenalidomide Accord (lenalidomide), for the treatment of multiple myeloma.


Other recommendations included granting two new pediatric-use marketing authorizations (PUMAs). Kigabeq (vigabatrin) was recommended for the treatment of infantile spasms (West's syndrome) and resistant partial epilepsy. Slenyto (melatonin) was recommended for the treatment of insomnia in children and adolescents with autism spectrum disorder or Smith-Magenis syndrome. The Committee also adopted a positive opinion for the new antibacterial, Xerava (eravacycline), for the treatment of complicated intra-abdominal infections in adults, and Ilumetri (tildrakizumab) for the treatment of moderate to severe plaque psoriasis.

Recommended cancer treatments included Braftovi (encorafenib) and Mektovi (binimetinib), for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation; Imfinzi (durvalumab), for the treatment of non-small cell lung cancer; and Verzenios (abemaciclib), for the treatment of locally advanced or metastatic breast cancer.

Source: EMA