Roche aims to extend shelf life of Xolair with new prefilled pen formulation

The FDA has approved a new prefilled syringe formulation for Roche’s asthma drug Xolair, as the Swiss company aims to prolong its shelf life.

Xolair (omalizumab) generated revenues of more than $1.7 million for Roche last year, but the drug has been on the market since 2003 and went off patent in the US and EU last year.

Luckily for Roche’s Genentech unit and US promotion partner Novartis, no-one has yet got a cheaper biosimilar approved to compete – and Roche is defending its position in the market with a more patient-friendly administration device.

Also approved for chronic idiopathic urticaria (CIU) – hives caused by an allergic reaction to a food or drug – the new formulation developed by Genentech prevents the need for healthcare providers to buy sterile water to reconstitute the drug before administration.

Roche has used a similar strategy to prop up sales of Rituxan (rituximab) cancer drug, which is available in markets in the US and EU as a subcutaneous injection lasting a few minutes, instead of a lengthy infusion.

Sandra Horning, chief medical officer and head of global product development at Roche, said: “Xolair has long been an important treatment option for people with allergic asthma and CIU.

“The prefilled syringe formulation reflects our continued commitment to provide healthcare professionals with choices to best support each patient's unique needs.”

Xolair is approved for the treatment of moderate to severe persistent allergic asthma in people six years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for CIU in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines.

In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade.