PD-1 inhibitors head latest crop of CHMP opinions

Eight new drugs were recommended for approval at the CHMP’s latest meeting, with cancer immunotherapies from Merck & Co and Bristol-Myers Squibb (BMS) headlining.

Merck’s Keytruda (pembrolizumab) was given a green light to treat advanced melanoma, an indication already backed by the CHMP for arch-rival Opdivo (nivolumab) from BMS which bagged a positive opinion for use as a therapy for non-small cell lung cancer (NSCLC) under a new Nivolumab BMS trade name.

Opdivo may have been in pole position among PD1 inhibitors in Europe and Japan, but Keytruda won the race to the US market, and as a result has pulled ahead in terms of early sales. Opdivo is said to be gaining ground, however, following its recent US approval for NSCLC.

A third cancer immunotherapy – United Therapeutics’ Unituxin (dinutuximab) – has been recommended for approval to treat high-risk neuroblastoma, a rare cancer that typically occurs in children.

Unituxin is designed to mop up any lingering cancer cells in patients treated with high-dose chemotherapy and an autologous stem cell transplant, reducing the risk that the cancer will recur, and has been designated an orphan drug for neuroblastoma treatment.

First PCSK9 inhibitor

Another highlight of the meeting was a positive opinion for Amgen’s cholesterol-lowering drug Repatha (evolocumab), the first PCSK9 inhibitor to reach this regulatory stage in Europe ahead of rival alirocumab from Sanofi/Regeneron.

Repatha was backed by the CHMP as a treatment for patients who are unable to meet cholesterol targets through the use of currently-available treatments such as statin drugs, as well as for people with the rare genetic disease homozygous familial hypercholesterolaemia.

Among the other recommendations, BMS also won backing for its HIV therapy Evotaz (atazanavir/cobicistat), which is already sold in the US following its approval by the FDA in February.

The drug is a follow-up to BMS’ big-selling Reyataz (atazanavir) drug, sales of which topped $1 billion last year, and stems from an alliance between BMS and Gilead Sciences, which developed cobicistat.

Other rulings by the CHMP included a positive opinion for Omeros London’s Omidria (phenylephrine/ketorolac) drug for ophthalmic indications, namely maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.  In the field of psoriasis, Janssen-Cilag’s Stelara (ustekinumab) gained a recommendation for use in adolescent patients from 12 years of age who are inadequately controlled by, or are intolerant to, systemic therapies or phototherapies.

All told, the CHMP has recommended approval of 34 new medicines and 24 new indication for existing drugs since the start of the year.

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Opdivo set to be first PD-1 approved in Europe

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