CHMP’s positive recommendations
The European Medicines Agency’s CHMP (Committee for Medicinal Products for Human Use) gave positive recommendations to seven medicines for the extension of therapeutic indications during its June meeting.
CHMP granted GlaxoSmithKline (GSK) changes in the marketing authorization of the drug Cervarix and included anal cancers related to oncogenic HPV (human papillomavirus). The full indications have been revised, and the new terms of marketing authorization include usage of vaccine for preventing premalignant damages such as cervical, vulvar, vaginal, and anal cancers caused by a certain oncogenic human papillomavirus. Other drugs for the treatment of HPV include Merck’s (MRK) Gardasil.
The CHMP also recommended a change in the terms of marketing authorization for Novartis’s (NVS) Ilaris and included the use of Ilaris for the treatment of Still’s disease. According to the revised terms of marketing authorization, the drug Ilaris will be indicated for the treatment of Still’s disease including Adult-onset Still’s disease, cryopyrin-associated periodic symptoms, and gouty arthritis.
According to the new terms of marketing authorization, Merck Sharp & Dohme’s Keytruda is also indicated for PD-L1 type non-small cell lung cancer. The drug was already approved for the use in the treatment of advanced melanoma.
Keytruda is one of the most important drugs for Merck, and it is undergoing one of the broadest clinical programs in oncology. The drug is under clinical studies for more than 30 tumor types in over 160 clinical trials.
The CHMP also recommended changes in the terms of marketing authorization for MSD’s Zontivity to be co-administered with acetylsalicylic acid for the reduction of atherothrombotic events in patients with myocardial infarction, and now also in the treatment of patients with the symptomatic peripheral arterial disease.
Novo Nordisk’s Ryzodeg
In the same meeting, the CHMP recommended changes in the terms of marketing authorization for Novo Nordisk’s (NVO) Ryzodeg and included the use of Ryzodeg in children above two years old for the treatment of diabetes mellitus.
The new terms of marketing authorization recommended by the CHMP for Roche’s RoActemra include the use of RoActemra in combination with methotrexate for the treatment of rheumatoid arthritis for patients who have not previously been treated with methotrexate.
The CHMP has also recommended the use of Alcon’s Nevanac for reducing the risk of postoperative macular edema in diabetes patients after cataract surgery. The drug was previously indicated for preventing the postoperative pain and inflammation after the cataract surgery.