Daily Brief: Limited NICE recommendation for Fasenra, Urovant takes aim at an IPO, Xtandi expands use

Limited NICE approval for AZ’s asthma drug Fasenra

NICE has published draft guidance recommending Fasenra (benralizumab), AstraZeneca’s treatment for people who have severe eosinophilic asthma.

However, the UK's cost-effectiveness watchdog says the drug should only be used in limited circumstances for eosinophilic asthma, when usual therapies such as inhaled corticosteroids and beta-agonists fails to control the condition.

NICE says the drug should only be used for people who have had at least three exacerbations in the last year, a blood eosinophil count of 400 or more cells per microlitre and only when GSK’s Nucala (mepolizumab) is not appropriate.

Teva’s Cinqaero is also on the NICE-approved list of treatments for this severe and potentially life-threatening form of asthma, having gained recommendation last year.

Fasenra, on the other hand, is given as an injection every 4 weeks for the first 3 doses and every 8 weeks following. The list price is £1,955 per 30 mg pre-filled syringe and the company has agreed a confidential discounted price.

Read the NICE documents here

Urovant prepares for IPO

Urovant Sciences is to make its debut on the Nasdaq exchange, looking to raise $150m from an IPO. The proceeds will fund phase III trials of its overactive bladder treatment candidate vibegron, which it in-licensed last year from Merck & Co.

The company, which was only established last year, is a subsidiary of Roivant and is based in Basel.

Urovant aims to investigate the drug’s use in overactive bladder (OAB), as well as another trial in OAB patients with benign prostatic hyperplasia, plus a third trial in patients with pain associated with irritable bowel syndrome (IBSs).

FDA approves broader use of Xtandi

Pfizer and Astellas have gained US approval for broader use of their prostate cancer treatment Xtandi.

The FDA says the drug can now be used in men with castration-resistant prostate cancer (CRPC) with non-metastatic CRPC, based on results from the phase III PROSPER trial.

The approval makes Xtandi the first and only oral medication FDA-approved for both non-metastatic and metastatic CRPC.

The expanded licence will help it compete with J&J’S rival treatment Zytiga, which has also been broadening into patients with earlier stage disease.