CHMP with new Chair – 13 meds recommended

Harald Enzmann follows Dr Tomas Salmonson, who has chaired the CHMP since September 2012 and led the introduction of the EMA’s PRIority MEdicines scheme (PRIME). 

In the last CHMP meeting led by  Salmonson the Committee recommended granting a marketing authorisation for SparkTherapeutics’ gene therapy Luxturna (voretigene neparvovec), for the treatment of adults and children with inherited retinal dystrophy caused by RPE65 gene mutations. Inherited retinal dystrophy is a rare genetic disorder which causes vision loss and usually leads to blindness. The orphan medicine, which previously received FDA market authorisation, is the 8th gene therapy approved globally.

Furthermore the CHMP recommended Eli Lilly Nederland B.V.’s migraine prevention medicine Emgality (galcanezumab) for the treatment of adult patients who have more than four migraine attacks per month. Emgality is a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP).

A new antibiotic, Vabomere (meropenem trihydrate / vaborbactam), originally developed by Rempex London Ltd, was recommended as therapy to fight difficult-to-treat infections with Gram-negative bacteria including complicated urinary tract infection (cUTI), and pyelonephritis; complicated intra-abdominal infection (cIAI)M; and hospital-acquired pneumonia (HAP), as well as ventilator associated pneumonia (VAP).

In addition, two orphan medicines received a positive opinion from the Committee: Bayer AG’s Jivi (damoctocog alfa pegol), recombinant factor VIII prodcuct for the treatment of haemophilia A, and Kyowa Kirin Ltd’s ant-CCR4-antibody Poteligeo (mogamulizumab) for the treatment of mycosis fungoides or Sézary syndrome.

The CHMP recommended granting marketing authorisations for the cancer medicines Alunbrig (brigatinib), developed by Takeda Pharma A/S, for second-line treatment of anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (NSCLC) and Oasmia Pharmaceutical AB’s taxane chemotherapeutic Apealea (paclitaxel) for the treatment of ovarian cancer.

Two HIV-1 blockers developed by MSD got the green light from the CHMP in September: Delstrigo (doravirine / lamivudine / tenofovir disoproxil), and Pifeltro (doravirine).

Also, three biosimilars aimed to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy received a positive opinion from the Committee: Mylan N.V.’s/ Biocon Ltd’s Fulphila (pegfilgrastim), Cinfa Biotech SL’s/Infarco Group’s Pelmeg (pegfilgrastim), and its competitor Ziextenzo (pegfilgrastim), developed by Sandoz.

The CHMP also granted a positive opinion for Buvidal (buprenorphine), a hybrid medicine developed by Camurus AB for the treatment of opioid dependence. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of a reference product and in part on new data.

The EMA also confirmed its prior refusal for marketing authorisation of Sarepta Therapeutics’ (former AVI Biopharma International Ltd) FDA-approved orphan medicine Exondys (eteplirsen) as treatment for Duchenne Muscular Dystrophy because it felt that the data submitted did not show the drug was effective.