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Shire and Baxalta drugs among CHMP's latest recommendations

New drugs for ADHD and haemophilia backed forEuropean approval

European Medicines Agency (EMA)

New treatments from Shire for ADHD and Baxalta for haemophilia were among this month's round of recommendations from the Committee for Medicinal Products for Human Use (CHMP).

The EMA advisers backed Shire's Intuniv (guanfacine) and Obizur (susoctocog alfa) from Baxalta for European approval.

The new drugs were among eight backed by the CHMP, among them Sanofi's new cholesterol treatment Praluent (alirocumab), and the Committee also recommended the use of GSK's malaria vaccine Mosquirix outside the EU.

The new drugs to receive a positive opinion from the CHMP this month were: 

• Shire's Intuniv to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years old for whom stimulants, another type of ADHD medicines, are not suitable or tolerated or have shown to be ineffective

• Baxalta's Obizur for the treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to factor VIII

• Sanofi's Praluent (alirocumab) for primary hypercholesterolaemia (heterozygous familial and non-familial) and mixed dyslipidaemia in adults

• Basilea's orphan drug Cresemba (isavuconazole), for the treatment of aspergillosis and mucormycosis - two life-threatening diseases with limited treatment options

• Keryx Biopharma's Fexeric (ferric citrate coordination complex) for the treatment of hyperphosphataemia in adults with chronic kidney disease 

• Merck Sharp & Dohme's Zerbaxa (ceftolozane / tazobactam) for the treatment of complicated intra-abdominal infections, acute pyelonephritis and complicated urinary tract infections

• Grunenthal's Zalviso (sufentanil) for the treatment of post-operative pain. A hybrid medicine, Zalviso's application relied in part on the results of studies carried out with a reference product and in part on new data

• ANPHARM Przedsiębiorstwo Farmaceutyczne's Ivabradine Anpharm (ivabradine) for the treatment of stable chronic angina pectoris and chronic heart failure. This medicine was submitted as an 'informed consent' application, allowing it to use data from a previously authorised medicine's dossier - with the consent of that marketing authorisation holder.

The CHMP's positive opinions will be sent to the European Commission to make the final decision on their EU marketing authorisations.

Article by
Dominic Tyer

27th July 2015

From: Sales

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