AZ's asthma and diabetes drugs get label boosts in EU

Two of AstraZeneca’s most important drugs have received a boost, after European regulators backed a pen allowing people to inject themselves with respiratory drug Fasenra, and agreed that cardiovascular benefits data could be added to the label of diabetes drug Forxiga.

The European Medicines Agency’s CHMP regulatory committee gave a positive opinion to add a self-administration option for asthma injection Fasenra (benralizumab), based on a new delivery method as a pre-filled, single-use auto-injector.

Fasenra already has a convenience advantage over two rivals from the same class, GlaxoSmithKline’s Nucala (mepolizumab) and Teva’s rival Cinqaero (reslizumab) as it is given every eight weeks, after the first three doses administered that are four weeks apart.

Both Nucala and Cinqaero, which are also interleukin-5 inhibitors, are injected every four weeks.

Following the CHMP’s nod, the drug’s label can be changed without need for confirmation from the European Commission.

AstraZeneca expects a regulatory decision by the FDA on self-administration and the new pre-filled, single-use auto-injector device in the second half of 2019.

Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries.

However, in May last year AZ said Fasenra had failed in a phase 3 trial in chronic obstructive pulmonary disease (COPD), saying it did not provide a statistically significant reduction in exacerbations, a blow to its development in this other indication. NICE has also restricted its funding for NHS patients.

The positive opinion for self-administration and the Fasenra pen is supported by the phase 3 GREGALE and GRECO trials, and the phase 1 AMES trial, respectively. The safety and tolerability of Fasenra in these trials were consistent with the known profile of the medicine.

At the same meeting late last week the CHMP said that diabetes drug Forxiga (dapagliflozin) could have its label changed to include new cardiovascular outcomes data.

The data from the DECLARE-TIMI 58 trial showed the SGLT2 class drug achieved a statistically significant reduction in the composite endpoint for hospitalisation for heart failure or CV death versus placebo, one of the two primary efficacy endpoints.

There were fewer major adverse CV events observed with Forxiga for the other primary efficacy endpoint, but this did not reach statistical significance.

It’s becoming increasingly common for pharma companies to try and show that drugs used to control blood sugar levels in diabetes patients bring cardiovascular benefits.

Eli Lilly and Boehringer Ingelheim were the first to do this with Jardiance, and other companies with drugs from SGLT2 and GLP-1 classes such as Johnson & Johnson and Novo Nordisk have followed the trend.