EMA recommends eight new medicines, refuses one

Regulatory NewsRegulatory News | 26 June 2020 |  By 

A committee of the European Medicines Agency (EMA) recommended that eight new medicines be approved at its June meeting, and issued a negative opinion on an anti-tumor drug.
The human medicines committee (CHMP) of EMA recommended a refusal of the marketing authorization for Daiichi Sankyo’s Turalio (pexidartinib), which was to be used to treat tenosynovial giant cell tumors. The agency cited concern for small improvement in clinical outcomes and uncertainty about duration of effect, together with potentially life-threatening adverse hepatic effects.
The committee recommended a conditional marketing authorization for Gilead’s Veklury (remdesivir) for the treatment of COVID-19 in those 12 years and older requiring supplemental oxygen.
Another conditional marketing authorization was recommended for Hansa Biopharma’s Idefirix (imlifidase) to treat patients waiting for a kidney transplant who are highly sensitized against their donor tissue and have an available deceased donor kidney for which they have a positive crossmatch test.
Marketing authorizations were also recommended for Vertex Pharmaceuticals’ Kaftrio (elexacaftor/tezacaftor/ivacaftor), the first triple therapy to treat cystic fibrosis for patients with certain genetic mutations, and for three biosimilar medications.
CHMP gave a favorable recommendation to Aybintio (bevacizumab), which is used to treat various cancers. Favorable recommendations were also received by Livogiva and Qutavina, biosimilars for teriparatide and used to treat osteoporosis.
Finally, two new hybrid applications for new medicines received a recommendation for marketing authorizations: Gencebok (caffeine citrate), used to treat primary apnea in premature newborns and Methylthioninium chloride Cosmo, to be used to enhance visualization of colorectal lesions during diagnostic procedures. “Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorized reference product and in part on new data,” explained EMA in its announcement of the CHMP meeting recommendations.
The committee recommended extending therapeutic indications for five already authorized medications: Cosentyx, Epclusa, Remsima, Xolair and Zavicefta.
The committee did not make recommendations on two applications for initial marketing authorizations because they were withdrawn. Sondelbay is another teriparatide formulation for osteoporosis, and Zemdri (plazomicin) was to be used for complicated urinary tract infections.


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