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European Medicines Agency

EMA recommends six medicines for approval

The European Medicines Agency has recommended six medicines for approval and concluded its review of retinoid medicines, warning that they can harm unborn children.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended six medicines for approval, including two biosimilars and one orphan medicine, at its most recent meeting held on 19–22 March 2018.

Among the medicines that received a positive opinion was dolutegravir/rilpivirine (Juluca, ViiV Healthcare UK Limited/Janssen Sciences Ireland UC) for the treatment of HIV infection, pemetrexed (Pemetrexed Krka, Krka d.d.), for the treatment of malignant pleural mesothelioma and non-small cell lung cancer; and prasugrel (Prasugrel Mylan, Mylan S.A.S) for the prevention of atherothrombotic events.

The biosimilar medicines that were recommended by the Committee were trastuzumab (Kanjinti, Amgen Europe B.V., BREDA) for the treatment of breast and gastric cancer, and infliximab (Zessly, Sandoz GmbH) for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

Rucaparib (Rubraca, Clovis Oncology UK Ltd), an orphan medicine, was recommended for a conditional marketing authorisation for the treatment of relapsed or progressive ovarian cancer.

Also during the meeting, the CHMP confirmed their decision, made in December 2017, to refuse the marketing authorisation for plitidepsin (Aplidin, Pharma Mar), a cancer medicine which was expected to be used to treat adults with multiple myeloma who have received at least three prior cancer treatments. The Committee’s main concerns with the drug were that the data from the main study presented showed only a modest increase in the time patients given the drug lived. In addition, severe side effects were reported more frequently by those taking plitidepsin.

Further negative opinions were adopted for betrixaban (Dexxience, Portola Pharma UK Limited), for the prevention of venous thromboembolism, and abaloparatide (Eladynos, Radius International Ltd), for the treatment of osteoporosis.

Also in the meeting, the CHMP recommended extensions of indications for cabozantinib (Cabometyx, Ipsen Pharma), fosaprepitant (Ivemend, Merck Sharp & Dohme Ltd) and evolocumab (Repatha, Amgen Europe B.V.), and started the re-examination of an extension of indications recommendation for sunitinib (Sutent, Pfizer Ltd).

In addition, the committee started a review of the use of omega-3 fatty acid medicines in patients who have had a heart attack, after research showed that they may not prevent recurrence of heart disease or stroke.

Finally, the CHMP concluded its review of retinoid medicines and confirmed that they can harm an unborn child and must not be used during pregnancy. A warning on the possibility that neuropsychiatric disorders, such as depression, may occur will also be included on the prescribing information for oral retinoids.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20204600

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