The Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMA) recently gave positive
) 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
) 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
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
Currently, we have a Neutral recommendation on Novartis.
Novartis carries a Zacks #3 Rank (Hold rating) in the short
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