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Teva set for FDA verdict on reslizumab early next year

Ruling for severe asthma therapy Cinquil expected by March 2016

Teva Pharma logo 

The clock has started ticking on Teva's US marketing application for severe asthma therapy Cinquil, with an FDA ruling now expected by March 2016.

The US regulator has accepted Teva's Biologics License Application (BLA) for Cinquil (reslizumab) for the treatment of adults and adolescents with breakthrough asthma attacks, despite inhaled corticosteroid therapy - and elevated levels of white cells calls eosinophils in the blood.

Reslizumab is an interleukin-5 inhibitor, in the same class as GlaxoSmithKline's mepolizumab - which has just been recommended for approval in adults only by an FDA advisory committee - and AstraZeneca's benralizumab, which is due to be filed in the US and Europe next year.

"Despite currently available medicines, uncontrolled asthma remains a serious problem for patients, physicians and healthcare systems, highlighting the need for targeted new treatment options," said Michael Hayden, Teva's global head of R&D and chief scientific officer.

Data from Teva's BREATH clinical trials programme for the antibody were reported earlier this year and showed the reduced breakthrough attacks compared to placebo by half whilst also improving lung function in patients with eosinophilic asthma, a group which accounts for around a third of all asthma patients.

The new IL-5 inhibitors - along with other new asthma biologics including Regeneron/Sanofi's IL-4 and IL-13-targeting dupilumab and AZ's IL-13 inhibitor tralokinumab - are expected to be used in the approximately 5% of asthma patients who cannot control their disease using inhaled bronchodilators and steroids.

Novartis already sells a biologic drug for severe asthma - Xolair (omalizumab) - although this is approved for a different form of allergic asthma in which immunoglobulin E activation is a key driver of symptoms. 

While the new biologics for eosinophilic asthma have been tipped to become a multibillion dollar product category in their own right, the number of new candidates coming through development within a couple of years of each other means that will have to be shared.

Predictions for the sales potential of individual products vary from a couple of hundred million dollars to $2bn-plus and - assuming regulatory approvals are forthcoming - GSK could get first-mover advantage with Teva following a few months later. For comparison, Xolair sales were around $600m in asthma last year.

It is worth noting that mepolizumab and benralizumab are delivered as a subcutaneous injection while reslizumab is administered intravenously, although Teva has a subcutaneous formulation in phase I trials.

For Teva, reslizumab is a key component of its plans to diversify its business away from its current reliance on multiple sclerosis blockbuster Copaxone (glatiramer acetate), which is facing the threat of generic competition in the US from September.

The company is currently pursuing a merger with Mylan - which is resisting its advances

Article by
Phil Taylor

16th June 2015

From: Sales



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