The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently gave positive opinions on Novartis’ (NVS - Free Report) Bexsero and Exjade (deferasirox).
Novartis is seeking European approval of Bexsero for protecting patients (2 months of age and older) from meningococcal group B (MenB) disease. If approved, Bexsero will be the first and only broad coverage MenB vaccine for all age groups including infants.
Novartis evaluated the tolerability profile and immunogenicity of Bexsero in a comprehensive clinical program including data from large phase II/III clinical trials with around 8,000 infants, children, adolescents and adults.
In most cases, MenB disease occurs within the first 7 months of life. The disease can easily be misdiagnosed, which can cause death within a day or may cause serious, life-long disabilities. As per the World Health Organization, one out of ten patients, who suffer from the disease, dies in spite of proper treatment. Some patients may also suffer from permanent brain damage, hearing damage or limb loss.
Following the approval, all the member states are set to assess the reimbursement schemes and decide on the inclusion of Bexsero within National Immunization Programs. The EU approval of Bexsero will come as a certain boost to Novartis’ Vaccines and Diagnostics segment. We note that companies like Pfizer Inc. (PFE - Free Report) are looking to enter the MenB vaccine market.
Meanwhile, Novartis is seeking European approval for Exjade to treat chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or insufficient in patients (aged 10 years and older) suffering from non-transfusion-dependent thalassemia (NTDT) syndromes.
On approval, Exjade will be the first oral treatment approved in the EU specifically for patients suffering from NTDT syndromes.
Exjade was evaluated in a placebo-controlled study, THALASS, of iron chelation in NTDT patients. Results from the study revealed a significant dose-dependent decrease in iron burden as compared to placebo. The study also revealed that Exjade was well tolerated, with the overall adverse event rate being similar to that of placebo.
We note that though the European Commission is not bound to follow the CHMP’s decision, it generally does so. The EU regulatory body will be announcing its final decision, which will be applicable to all the EU and European Economic Area (EEA) countries, within three months of the advisory body’s recommendation.
Currently, we have a Neutral recommendation on Novartis. Novartis carries a Zacks #3 Rank (Hold rating) in the short run.