Novartis treatments set for approval
pharmafile | November 19, 2012 | News story | Sales and Marketing |Â Â Bexsaro, CHMP, Novartis, exjadeÂ
Two Novartis drugs, meningococcal vaccine Bexsero and iron chelation therapy Exjade, have been given positive opinions by the CHMP, with European approval likely to follow next year.
Bexsero (meningococcal group B vaccine) is aimed at preventing MenB infections, the leading cause of meningitis.
The sudden, aggressive illness can lead to death within 48 hours, with infants at the highest risk for infection by MenB – designed to be used from two months of age, Bexsero would be the first broad coverage MenB vaccine to help protect all age groups.
Novartis says its tolerability and immunogenicity has been proved in Phase II/III trials involving almost 8,000 infants, children, adolescents and adults.
The vaccine was developed using so-called ‘reverse vaccinology’, decoding the genome sequence of MenB and selecting proteins most likely to be broadly-effective vaccine candidates.
Meanwhile Exjade (deferasirox) has been recommended to treat iron overload in patients with non-transfusion-dependent thalassemia (NTDT) syndromes – and if approved would be the first oral treatment specifically for this purpose.
Thalassemia refers to a series of anemia-causing genetic disorders affecting red blood cell production, affecting at least three quarters of a million people worldwide, with NTDT syndromes characterised by patients absorbing excess iron through their intestines.
Liver fibrosis, cirrhosis, blood clots, bone disease, pulmonary hypertension and vascular and endocrine diseases are common complications, and Exjade has been shown to reduce iron compared to placebo.
The CHMP opinion suggests NTDT patients aged ten and over requiring chelation therapy should be given the drug when deferoxamine therapy is contraindicated or inadequate.
Most NTDT patients are of South- and South-east Asian, Mediterranean or Middle Eastern origin.
Exjade is already indicated in the EU for the treatment of chronic iron overload due to blood transfusions in various other groups of thalassemia sufferers.
Adam Hill
Related Content
Novartis receives SMC approval for early breast cancer treatment
Novartis has announced that its treatment for early breast cancer, Kisqali (ribociclib), has received approval …
Novartis candidate for Sjögren’s disease presents positive results
Novartis has reported positive results from two phase 3 clinical trials – NEPTUNUS-1 and NEPTUNUS-2 …
First malaria medicine for infants under 4.5kg receives approval
Coartem (artemether-lumefantrine) Baby, or Riamet, has been approved by Swissmedic as the first malaria medicine …
