EMA’s CHMP Recommends 13 New Medicines for Approval

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of 13 new medicines, including three orphan drug candidates, the agency announced on Sept. 21, 2018.

Among the recommendations for approval are Spark Therapeutics’ gene therapy, Luxturna (voretigene neparvovec), an orphan drug for treating inherited retinal dystrophy caused by RPE65 gene mutations, a rare genetic disorder which causes vision loss and usually leads to blindness, and Eli Lilly and Company’ s Emgality (galcanezumab), a monoclonal antibody for preventing migraine that belongs to a new class of medicines that block calcitonin gene-related peptide (CGRP) activity.

The committee also recommend granting marketing authorization for The Medicines Company’s new antibiotic, Vabomere (meropenem trihydrate / vaborbactam), for treating various severe infections in adults.

Two new cancer medicines, Takeda Pharmaceutical’s Alunbrig (brigatinib), for treating anaplastic lymphoma kinase-positive advanced non-small cell lung cancer, and Oasmia Pharmaceutical’s Apealea (paclitaxel), for treating ovarian cancer, were also recommended for approval.

The two other orphan medicines to receive a positive opinion are Bayer’s Jivi (damoctocog alfa pegol), for treating hemophilia A, and Kyowa Hakko Kirin's Poteligeo (mogamulizumab), for treating mycosis fungoides or Sézary syndrome. The committee also gave a positive opinion to Merck & Co.’s Delstrigo (doravirine / lamivudine / tenofovir disoproxil) and Pifeltro (doravirine), both for treating HIV-1 infection.

In addition, the committee also recommend approval of three biosimilars to Amgen’s Neulasta (pegfilgrastim) intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy: Mylan’s Fulphila (pegfilgrastim), Cinfa Biotech’s Pelmeg (pegfilgrastim), and Sandoz’s Ziextenzo (pegfilgrastim).

Finally, the committee granted a positive opinion for Camurus’ Buvidal (buprenorphine), a hybrid medicine for treating 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 recommendations

Upon follow-up re-examination, CHMP also had the following negative recommendations on new medicines: 
• Sarepta Therapeutics’ Exondys (eteplirsen), for which Sarepta requested a re-examination following the committee’s negative opinion adopted in May 2018. Upon consideration of this request, the committee confirmed its previous recommendation to refuse the granting of a marketing authorization. The drug was approved in the United States by FDA in September 2016.
• Amgen’s Blincyto (blinatumomab) and Bristol Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab), for which the companies requested re-examination of the committee’s negative opinions adopted in July 2018. The CHMP will now re-examine the opinions and issue final recommendations.

Update on valsartan review

The committee is also 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.

Application withdrawals

Applications for initial marketing authorizations for TMC Pharma Services’ Entolimod TMC (entolimod) and SciPharm Sàrl’s Treprostinil SciPharm Sàrl (treprostinil) have been withdrawn. Treprostinil SciPharm Sàrl was intended for the treatment of chronic thromboembolic pulmonary hypertension.

Source: EMA