Some three months after getting approved in the USA, Novartis has moved a step closer to getting its blood pressure drug Rasilez cleared in Europe after getting a recommendation from regulators.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion on Rasilez (aliskiren) and if fully approved, it will be the first new type of high blood pressure treatment in more than a decade. The recommendation is based on data from more than 7,800 patients in 44 clinical studies which showed that Rasilez, which is partnered with Swiss biotechnology group Speedel, provided significant blood pressure reductions for 24 hours and beyond. Furthermore, the drug provided added efficacy when used in combination with other commonly-used blood pressure medications.
Novartis Pharma chief executive Thomas Ebeling noted that the news comes just days after the US approval of its new fixed combination therapy Exforge (valsartan/amlodipine) and following the Likely European approval of Rasilez, “our new antihypertensive medicines will be made available to patients in the US, Europe and elsewhere as quickly as possible”. The drug received its first approval in March from the US Food and Drug Administration and is sold as Tekturna.
Meantime, GlaxoSmithKline’s Atriance has been recommended for approval in Europe as a treatment of rare forms of leukaemia and lymphoma.
The CHMP has issued a positive opinion to Atriance (nelarabine) for the treatment of T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma in patients who don't respond to or relapse after two chemotherapy regimens. The drug had been granted orphan drug status by the EMEA in June 2005.
GSK noted that T-ALL and T-LBL are rare and difficult to treat and there are only a few hundred cases of relapsed T-ALL each year in Europe. Patients with T-ALL and T-LBL tend to have a worse prognosis than patients with B-cell disease, and Paolo Paoletti, the firm’s global head of oncology R&D, said that “nelarabine may offer some patients the chance to go on to have potentially curative treatment, such as a stem cell transplant”.
Nelarabine was approved by the US Food and Drug Administration in October 2005 and it sold across the Atlantic as Arranon.