In its latest monthly meeting, the European Medicines Agency’s human medicines committee (CHMP) has recommended five novel medicines, as well as two generics.
Firstly, the committee gave a positive opinion to Novartis’ Isturisa (osilodrostat) for the treatment of Cushing’s syndrome. The organisation recommended granting a marketing authorisation to the company, to treat the rare disorder that occurs when the body produces too much corticosteroid hormone.
Novartis received another positive opinion for Mayzent (siponimod), for the treatment of adult patients with secondary progressive multiple sclerosis “with active disease evidenced by relapses or imaging features of inflammatory activity.”
The Mayzent recommendation is important as until now “there was little to offer patients who had reached the secondary progressive stage of the disease,” but the drug “has a positive impact on reducing both cognitive and physical decline, offering renewed hope for people living with active secondary progressive multiple sclerosis”, explained Dr Eli Silber, consultant neurologist at King’s College Hospital.
A conditional marketing authorisation was recommended for Polivy (polatuzumab vedotin), a Roche therapy for the treatment of relapsed/refractory diffuse large B-cell lymphoma, and another positive opinion was given to Jazz Pharma’s Sunosi (solriamfetol) for excessive daytime sleepiness in patients with narcolepsy and obstructive sleep apnoea.
Robert Iannone, executive vice president of Jazz Pharmaceuticals says that the “milestone” brings the company “one step closer to potentially providing a new treatment option for people living with these sleep disorders in Europe.”
The organisation went on to give a “yes” to Rigel’s Tavlesse (fostamatinib) for the treatment of primary immune thrombocytopenia – an acquired immune-mediated disorder characterised by the destruction of platelets and impaired platelet production.
In addition to these five novel treatments, the committee recommended granting marketing authorisations for two generic medicines: Clopidogrel/Acetylsalicylic acid Mylan (clopidogrel / acetylsalicylic acid) and Deferasirox Accord (deferasirox). These meds were recommended for the secondary prevention of atherothrombotic events and chronic iron overload due to blood transfusions in patients with beta thalassaemia and other anaemias, respectively.
Further to the recommendations, the CHMP announced that it will re-examine its opinion on D&A Pharma’s Hopveus (sodium oxybate), and issue a final decision.
Other decisions include extending the of indication for Roche’s Kadcyla (trastuzumab emtansine) and Celgene’s Revlimid (lenalidomide), and the committee revealed the outcomes of its review on Xeljanz (tofacitinib), citing increased risk of blood clots in the lungs and in deep veins in patients who are already at high risk.
