The Committee for Medicinal Products for Human Use (CHMP) backed nine new drugs for approval at its meeting last week, including two from AstraZeneca (AZ).
The tally of new positive opinions – which brings the total for the year to 93 – included a recommendation for conditional marketing approval for AZ’s Tagrisso (osimertinib) for the treatment of non-small cell lung cancer.
AZ has filed for accelerated approval of the drug as a treatment for epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC, an indication which has already been approved in the US.
The drug is a third-generation EGFR inhibitor, designed to overcome resistance to older drugs in the class such as Roche/Astellas’ Tarceva (erlotinib), AZ’s Iressa (gefitinib) and Boehringer Ingelheim’s Giotrif (afatinib). Tagrisso was recently made available to some UK patients under the country’s Early Access to Medicines Scheme (EAMS).
Another medicine for lung cancer, Portrazza (necitumumab) from Eli Lilly, was also backed by the CHMP for the treatment of squamous NSCLC. Necitumumab was also approved by the FDA recently, on the strength of data suggesting it can extend survival, becoming the first biologic therapy cleared for first-line use in NSCLC.
AZ’s second positive opinion was for Zurampic (lesinurad), a drug for the treatment of excess uric acid in the blood (hyperuricaemia) seen in patients with gout. The recommendation is another boost for a candidate that has been deemed as a wild card in AZ’s pipeline, after an FDA advisory committee backed approval in the US in October.
If approved, lesinurad will be the first selective uric acid reabsorption inhibitor (SURI) to treat patients with inadequately controlled gout in both regions.
Bayer moved close to full EU approval of its Iblias/Kovaltry (octocog alfa; BAY 81-8973) haemophilia A treatment, which will extend the company’s Kogenate franchise with a new plasma-free option that does not use components of animal or human origin.
The products are based on an unmodified full-length recombinant factor VIII compound that in trials has been shown to control bleeds and provide protection from bleeds when used prophylactically two or three times per week.
The CHMP also backed marketing authorisation of Vaxelis, a vaccine against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B. The vaccine was developed by Sanofi Pasteur MSD in a joint venture between Sanofi and Merck & Co.
Laboratoires CTRS bagged a positive opinion for Neofordex, a 40mg tablet formulation of the corticosteroid dexamethasone, as a treatment for multiple myeloma. The product has orphan drug status in this indication.
The CHMP also recommended Shield’s Feraccru (ferric maltol) for the treatment of iron deficiency anaemia in patients with inflammatory bowel disease, and Accord Healthcare’s generic medicine Caspofungin Accord (caspofungin) for the treatment of fungal infections.
The panel rejected an application for Dropcys (mercaptamine hydrochloride) – from Lucane Pharma – which was intended to prevent and treat cystinosis affecting the eye.
AZ’s Brilinta
Meanwhile, the CHMP also recommended approval of AZ’s Brilique (ticagrelor) for the treatment of patients with a history of heart attack and at high risk of having a further atherothrombotic event.
The label change is based on the results of the 21,000-PEGASUS study, which showed ticagrelor plus low-dose aspirin was significantly more effective than placebo plus aspirin at reducing the risk of dying from cardiovascular causes, having another heart attack, or having a stroke.
The FDA approved the updated wording for ticagrelor – which is sold in the US as Brilinta – in September.