CHMP puts eight new medicines forward for approval

The European Medicines Agency's human medicines committee (CHMP) has put forward eight medicines for approval at its April meeting.

Novartis' Enerzair Breezhaler was backed as potential first-in-class triple combination therapy containing indacaterol, glycopyrronium and mometasone for the treatment of asthma.

Despite existing inhaled therapies, over 45% of patients with moderate-to-severe asthma remain uncontrolled, and are therefore at a higher risk of exacerbation, hospitalisation or death. This highlights the need for new treatment options to achieve optimal disease control and improved quality of life.

Enerzair Breezhaler also offers a 'digital companion' consisting of an app and sensor which provides inhalation confirmation, medication reminders and access to objective data, to better support therapeutic decisions and enhanced adherence.

“Once-daily IND/GLY/MF has the potential to improve asthma control for patients whose lives are still impacted by their disease, despite existing inhaled therapies. Additionally, we are pleased to bring an innovative sensor and app companion supplied with IND/GLY/MF to patients to help support enhanced adherence,” said Linda Armstrong, respiratory development unit head, Novartis Pharmaceuticals.

The CHMP also adopted a positive opinion for Novartis' Zimbus Breezhaler (indacaterol/lycopyrronium/mometasone), a duplicate of Enerzair Breezhaler for the treatment of asthma.

Elsewhere, Pfizer's Daurismo (glasdegib) was recommended for the treatment of acute myeloid leukaemia.

According to the Agency, the benefits of Daurismo are its ability to improve the overall survival when combined with low-dose cytarabine, while the most common side effects are nausea, decreased appetite, fatigue, muscle spasms, diarrhoea, dysgeusia, constipation, abdominal pain, rash and vomiting. The most frequent severe adverse reaction reported was fatigue.

Bristol Myers Squibb's Reblozyl (luspatercept) was granted a positive opinion for the treatment of adults with transfusion-dependent anaemia associated with myelodysplastic syndromes or beta-thalassaemia. If approved, the drug will offer a new class of therapy for eligible patients.

The CHMP also endorsed: the biosimilar Insulin aspart Sanofi (insulin aspart) for diabetes mellitus; Accord's hybrid medicine Cabazitaxel Accord (cabazitaxel) for patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen; Paliperidone Janssen-Cilag International (paliperidone), which was evaluated in an informed consent application, for the treatment of schizophrenia; and Accord's generic Fingolimod Accord (fingolimod), for relapsing-remitting multiple sclerosis with high disease activity.

On the down side, following a re-examination of D&A Pharma's Hopveus (sodium oxybate) marketing application the CHMP stuck with its original rejection of the drug, which was intended for the treatment of alcohol dependence.

1st May 2020

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