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FDA panel backs new antifungal Cresemba

Basilea/Astellas drug tipped to become a $500m product

FDA headquarters White Oak 

An FDA advisory committee has voted in favour of approval for Basilea/Astellas novel antifungal Cresemba, tipped by some analysts to become a $500m-plus product at peak.

The panel gave its blessing to Cresemba (isavuconazole) in both intravenous and oral formulations as treatments for adults with invasive aspergillosis and invasive mucormycosis, two life-threatening fungal infections typically seen in immunocompromised patients.

Current FDA-approved therapies for treatment of invasive aspergillosis include amphotericin formulations, itraconazole, voriconazole, and Merck & Co's Cancidas (caspofungin). At the moment, only amphotericin B is approved for the treatment of invasive mucormycosis.

In trials, Cresemba was found to be equivalent to voriconazole - the recommended first-line treatment for patients with invasive fungal infections, on safety and efficacy measures including al-cause mortality. It was also shown to be safe and effective in patients with kidney problems, a group in which voriconazole may require dose adjustment.

Cresemba had been awarded Qualified Infectious Disease Product (QIDP) status by the FDA as a drug intended to treat serious or life-threatening infections that have the potential to pose serious threat to public health.

Switzerland-based Basilea and Astellas are conducting a phase III trial in a third indication - invasive candidiasis - which is expected to generate results later this year. Cresemba has also been awarded QIDP status by the FDA in this type of fungal infection.

Astellas acquired a worldwide license to isavuconazole from Basilea in 2010 in a deal valued at up to 550m Swiss francs, with the Swiss company also standing to receive double-digit royalties on sales. Isavuconazole has also been submitted for approval in Europe with a verdict due before the end of 2015.

The global market for human antifungal therapeutics is expected to grow to nearly $13.9bn by 2018, with a five-year compound annual growth rate (CAGR) of 3.2%, with the rate of infections rising due to increased use of antibiotics and immunosuppressive drugs, including cancer therapies, according to market research firm BCC.

Article by
Phil Taylor

23rd January 2015

From: Sales

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