EMA committee recommends seven therapies from Roche, GSK, MSD and more

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has voiced its recommendation of a raft of products in a number of therapeutic areas, including candidates from GlaxoSmithKline, Roche and MSD.

Among them, Roche’s Hemlibra (emicizumab) was recommended for the treatment of routine bleeding episodes in patients with haemophilia A with factor VIII inhibitors. The drug is under accelerated review, and is supported by data from two studies which show that patients who used it experienced an up to 87% reduction in targeted bleeds compared to no prophylaxis. In addition, interim data demonstrated that 87% of trial participants under 12 experienced no targeted bleeds.

This data adds to evidence revealed last year by Roche and partner Chugai which showed that Hemlibra significantly lowered the number of treated bleeds over time when administered every week or once every two weeks in patients over 12. The drug was approved by the FDA in November for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors

GSK’s shingles vaccine Shingrix was also recommended for the prevention of herpes zoster and post-herpetic neuralgia in adults 50 years of age or older, with the CHMP noting that the treatment showed the ability to "significantly decrease the incidence of herpes zoster and consequently of post-herpetic neuralgia compared with placebo."

Analysts expect Shingrix to generate £1 billion a year by 2023. A final decision on the approval of the drug will be made in April, following its approval by the FDA in October for the prevention of herpes zoster in adults over 50.  

MSD scored three recommendations off the back of its oral SGLT2 inhibitor Steglatro (ertugliflozin), which was backed on its own for the treatment of type 2 diabetes, as well as a fixed-dose combination with metformin which will be called Segluromet, and also as a fixed-dose combination with the firm’s DPP-4 inhibitor Januvia (sitagliptin), which will be known as Steglujan.

Steglatro was found to significantly reduce A1C levels as monotherapy versus placebo, as well as when co-administered with Januvia compared to either drug alone. The data adds to last year’s findings that the drug significantly lowered blood glucose levels when used in combination with metformin in adults with type 2 diabetes uncontrolled on metformin monotherapy, while the Januvia/ertugliflozin combination also achieved significantly greater reductions in A1C versus placebo. The FDA approved the drug and its two combinations last month.

Also recommended was Chiesi’s long-term enzyme replacement therapy Lamzede (velmanase alfa) for the treatment of mild to moderate forms of the rare inherited enzyme disorder alpha-mannosidosis, a condition for which there is no cure and can lead to death in childhood.

Semglee, Mylan and Biocon’s biosimilar version of insulin glargine product Lantus, also received recommendation for use in patients at least two years old after its efficacy was proven to be comparable to its reference product in the treatment of type 1 and type 2 diabetes last year. The decision follows a lawsuit against the manufacturers by Sanofi, the owner of Lantus, over allegations the pair’s copy infringes 18 patents.