Six new therapies backed for EU approval

Six medicines have taken a big step towards European approval having been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

The batch includes one orphan medicine, Clovis Oncology UK’s Rubraca (rucaparib), which has been developed for the treatment of relapsed or progressive ovarian cancer.

The drug is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes that blocks the repair of damaged DNA in cancer cells, and, as a result, causes the cancer cells to die.

ViiV Healthcare UK’s Juluca received a positive opinion for the treatment of HIV.

The once-daily pill is comprised of ViiV’s dolutegravir, an integrase strand transfer inhibitor, and Janssen’s rilpivirine, a non-nucleoside reverse transcriptase inhibitor.

According to the CHMP, the benefit with Juluca, which was approved in the US last November, is its ability to maintain viral suppression of HIV strains that lack resistance to integrase inhibitors.

The Committee gave its blessing to two biosimilar medicines: Amgen’s Kanjinti (trastuzumab) for the treatment of breast and gastric cancer; and Sandoz’ Zessly (infliximab) for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

Two generics were also backed for approval: Pemetrexed Krka (pemetrexed), for the treatment of malignant pleural mesothelioma and non-small cell lung cancer; and Prasugrel Mylan (prasugrel), for the prevention of atherothrombotic events.

On the downside, Portola Pharma UK’s Dexxience (betrixaban) was not recommended for approval, as the agency felt that clinical data did not satisfactorily show that the drug’s benefits outweighed its risk when used for preventing blood clots in patients admitted to hospital for recent medical illness.

Similarly, Radius International’s experimental osteoporosis therapy Eladynos (abaloparatide) was rejected by the CHMP, which said the main study did not satisfactorily show that the therapy is effective at preventing non-vertebral fractures in women who have been through the menopause.

The data from two of the study sites were not reliable and had to be excluded as the study had not been conducted in compliance with ‘good clinical practice’ at those sites, the Committee noted, and also listed safety concerns about the medicine’s effects on the heart, such as increases in heart rate and palpitations.

The CHMP also confirmed its previous recommendation to refuse the granting of a marketing approval for Pharma Mar’s Aplidin (plitidepsin) for multiple myeloma.

Data from the main study showed only a modest increase of around one month in the time patients given Aplidin lived without their disease getting worse, compared with those treated with dexamethasone alone, while improvement in overall survival was not sufficiently demonstrated, the group concluded.

With regards to safety, severe side effects were reported more frequently with the combination of Aplidin and dexamethasone than with dexamethasone alone, and so the Committee could not conclude that the medicine’s benefits outweighed its risks.

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