Novartis’ asthma triple heads CHMP’s latest meeting

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended eight new medicines for approval, including Novartis’ respiratory triple therapy Enerzair Breezhaler.

The panel said Enerzair (indacaterol/glycopyrronium/mometasone) and a duplicate products called Zimbus should be approved by the EU’s regulator for uncontrolled asthma, putting Novartis in front of GlaxoSmithKline’s rival three-drug therapy Trelegy (vilanterol /umeclidinium/fluticasone furoate) for this indication.

Trelegy is already approved to treat chronic obstructive pulmonary disease (COPD), making sales of almost £200m in the first three months of the year, but GSK only filed for approval of the drug in asthma in Europe in February.

If approved in the usual two to three month timeframe after a CHMP positive opinion, Novartis’ drug looks set to reach the market months ahead of Trelegy for uncontrolled asthma. It has another claim to fame, as Novartis says it is the first asthma therapy with an optional digital sensor and app to improve compliance.

The CHMP also recommended approval of two orphan drugs – Pfizer’s Daurismo (glasdegib) for the treatment of acute myeloid leukaemia and Bristol-Myers Squibb’s Reblozyl (luspatercept), a first-in-class erythroid maturation agent (EMA).

Hedgehog pathway inhibitor Daurismo was backed for use in combination with low-dose cytarabine in newly-diagnosed AML patients who are not candidates for standard chemotherapy, and indication that was approved in the US towards the end of 2018.

Reblozyl got the nod for adults with transfusion-dependent anaemia associated with rare blood disorder beta thalassaemia as well as myelodysplastic syndrome (MDS), a form of blood cancer. The drug was formerly developed by Celgene, which was finally acquired by BMS and has also been approved for these indications in the US. It has been tipped as a $2bn-plus blockbuster.

French drugmaker Sanofi claimed a positive opinion from the CHMP for its biosimilar insulin aspart, a copycat version of Novo Nordisk’s NovoLog. Also sold as NovoRapid, it was the Danish drugmaker’s top-selling insulin product last year with sales of $2.6bn, and last June Sanofi’s drug was the first biosimilar version to be submitted for approval in Europe.

Accord Healthcare picked up an approval recommendation for Cabazitaxel Accord (cabazitaxel) for the treatment of patients with hormone refractory metastatic prostate cancer, previously treated with a docetaxel-containing regimen, that will compete with Sanofi’s Jevtana brand of the drug.

Johnson & Johnson’s Janssen-Cilag unit also got the go-ahead for a long-acting injectable formulation of antipsychotic drug paliperidone for schizophrenia, and a generic version of Novartis oral multiple sclerosis drug Gilenya (fingolimod) from Accord.

Meanwhile, the committee also gave its blessing to a new subcutaneous formulation of Johnson & Johnson’s intravenous multiple myeloma therapy Darzalex (daratumumab) that could protect the franchise from competition with Sanofi’s IV rival Sarclisa (isatuximab) which was backed by the CHMP at its March meeting.

It also recommended extended indications for already approved drugs, including:

• Pierre Fabre’s Braftovi (encorafenib) in combination with cetuximab for the treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer;
• Sanofi’s Cablivi (caplacizumab) for adolescents with acquired thrombotic thrombocytopenic purpura (aTTP) as well as adults;
• Obvius Investment’s Carmustine Obvius as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (HPCT) in malignant haematological diseases;
• Pfizer’s Ecalta (anidulafungin) for invasive candidiasis in children aged from 1 month to 18 years;
• Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) in children aged over three;
• Vertex Pharma’s Kalydeco (ivacaftor) to extend the specific cystic fibrosis mutations that make patients eligible for treatment;
• Eli Lilly’s Taltz (ixekizumab) for the new indication of axial spondyloarthritis; and
• Alexion’s Ultomiris (ravulizumab) in atypical haemolytic uremic syndrome (aHUS).