The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) elected Harald Enzmann as its new chair at its September 2018 meeting, for a three-year mandate starting on 21 September.
This week’s meeting of the CHMP was the last plenary meeting chaired by Dr Tomas Salmonson, who retires as chair after serving for two three-year mandates, the maximum allowed by the legislation. Dr Salmonson is a senior scientific advisor at the Swedish Medical Products Agency, where he has worked since 1986. He has been a member of the CHMP for more than 18 years and has served as chair of the Committee since September 2012.
EMA would like to thank Dr Salmonson for his outstanding contribution to the work of the CHMP, which has enabled progress in key areas of public health. In 2016, he was closely involved in the launch of the PRIority MEdicines scheme (PRIME), which supports the development of promising new medicines in the European Union (EU). Under his leadership, the Committee improved its benefit-risk methodologies considering new scientific developments and technological advances and it broke new ground in its engagement with key stakeholders, such as international regulators, health technology assessment bodies and patients, who have started to participate in the Committee’s decision-making on medicines. Over the six years at the helm of the CHMP, he has promoted EMA and the EU regulatory system as a whole as a hub of excellence for medicines regulation for the benefit of public health in the EU and around the world.
Thirteen medicines recommended for approval, including three orphans
The Committee recommended granting a marketing authorisation for the gene therapy Luxturna (voretigene neparvovec), for the treatment of adults and children with inherited retinal dystrophy caused by RPE65 gene mutations, a rare genetic disorder which causes vision loss and usually leads to blindness. Luxturna was designated as an orphan medicine during its development.
The CHMP recommended granting a marketing authorisation for Emgality (galcanezumab), a monoclonal antibody for the prevention of migraine. Emgality belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks.
The CHMP recommended granting a marketing authorisation for a new antibiotic, Vabomere (meropenem trihydrate / vaborbactam), for the treatment of various severe infections in adults. The development of new and effective antibiotics is one of the most powerful tools to fight antimicrobial resistance.
Two more orphan medicines received a positive opinion from the Committee: Jivi (damoctocog alfa pegol), for the treatment of haemophilia A (congenital factor VIII deficiency), and Poteligeo (mogamulizumab), for the treatment of mycosis fungoides or Sézary syndrome.
The CHMP recommended granting marketing authorisations for two cancer medicines: Alunbrig (brigatinib), for the treatment of anaplastic lymphoma kinase-positive advanced non-small cell lung cancer, and Apealea(paclitaxel), for the treatment of ovarian cancer.
Delstrigo (doravirine / lamivudine / tenofovir disoproxil) and Pifeltro (doravirine) received positive opinions for the treatment of HIV-1 infection.
Three biosimilar medicines intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy received a positive opinion from the Committee: Fulphila (pegfilgrastim), Pelmeg (pegfilgrastim) and Ziextenzo (pegfilgrastim).
The CHMP granted a positive opinion for Buvidal (buprenorphine), a hybrid medicine 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.
Negative recommendation on a new medicine following re-examination
The applicant for Exondys (eteplirsen) requested a re-examination of the Committee’s negative opinion for this medicine adopted at the May 2018 meeting. After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed its previous recommendation to refuse the granting of a marketing authorisation for this medicine.
Seven recommendations on extensions of therapeutic indication
The applicants for Blincyto (blinatumomab), Opdivo (nivolumab) and Yervoy (ipilimumab) have requested re-examination of the Committee’s negative opinions for these medicines adopted at the July 2018 meeting. The CHMP will now re-examine the opinions and issue final recommendations.
Update on valsartan review
The CHMP is expanding its review of impurities in valsartan following the detection of very low levels of N-nitrosodiethylamine (NDEA) in another active substance, losartan, made by Hetero Labs in India. As a result of the detection of this impurity by German authorities, the review will now include medicines containing four other ‘sartans’, namely, candesartan, irbesartan, losartan and olmesartan.
Withdrawals of applications
Applications for initial marketing authorisations for Entolimod TMC (entolimod) and Treprostinil SciPharm Sàrl (treprostinil) have been withdrawn. Entolimod TMC was intended to be used to reduce the risk of death following exposure to potentially lethal amounts of radiation. Treprostinil SciPharm Sàrl was intended to be used to treat chronic thromboembolic pulmonary hypertension.