Novartis earns EMA and FDA nods for Jakavi and Bexsero
pharmafile | January 26, 2015 | News story | Sales and Marketing | Bexsero, Cancer, EU, FDA, Jakavi, Novartis, US, meningitis, ruxolitinib
Novartis has secured the regulatory go-ahead for two of its drugs, after the EMA recommended Jakavi for a rare blood cancer and the FDA approved meningitis B vaccine Bexsero following a rapid review.
Jakavi (ruxolitinib) is already licensed in Europe for certain forms of myelofibrosis. The positive opinion by the EMA’s Committee for Medicinal Products for Human Use means that the drug’s licence is likely to be extended to include adult patients with polycythemia vera (PV) who are resistant to or intolerant of the current standard treatment, hydroxyurea.
Novartis says if the recommendation is signed-off by the European Commission, Jakavi will be the first targeted treatment option for patients with this illness. PV is a chronic, incurable blood cancer that happens when the body produces too many blood cells. This can cause serious cardiovascular complications, such as stroke and heart attack.
“This positive CHMP opinion is encouraging news for patients with polycythemia vera who need effective treatment options,” says Alessandro Riva, global head of Novartis Oncology development and medical affairs.
“If approved, Jakavi will be the first-ever targeted therapy for polycythemia vera in the EU, a positive step forward for the rare blood cancer community in Europe and a major development in Novartis’ continued commitment to help patients with high unmet needs.”
Meanwhile in the US the company’s meningitis B vaccine has been granted accelerated approval by the FDA. Bexsero is already licensed in 37 countries to prevent invasive disease caused by meningococcal group B in adolescents and young adults – from 10 to 25 years of age.
Novartis says in a statement that Bexsero is the only meningitis B vaccine approved in the US with a two-dose regimen and a flexible dosing schedule. As part of the accelerated approval process, the firm will complete ongoing studies with the FDA to confirm the effectiveness of the vaccine.
Andrin Oswald, division head of Novartis Vaccines, says: “While rare, meningitis B is a devastating disease that can hit anyone anytime, especially teenagers and children. This approval is an important milestone towards our goal of helping to prevent any further loss of life.”
Lilian Anekwe
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