FDA approves new anti-fungal treatment
pharmafile | March 9, 2015 | News story | Sales and Marketing | Astellas, Basilea, FDA, US, cresemba, isavuconazonium sulfate, zygomycosis
The FDA has given the OK to Astellas and Basilea for their new treatment in adults with a rare but serious fungal infection.
Cresemba (isavuconazonium sulfate) is a new treatment for adults with invasive aspergillosis and invasive mucormycosis (also known as zygomycosis) – infections caused by the Aspergillus and Mucorales species of fungi, respectively.
These infections occur most often in people with weakened immune systems, for example people having cancer treatment.
Cresemba was given a priority FDA review as part of the Qualified Infectious Disease Product (QIDP) programme. The FDA say a drug given this status must be an “antibacterial or antifungal drug products that treats serious or life-threatening infections”.
Under the Generating Antibiotic Incentives Now (GAIN) initiative, which was part of the FDA’s Safety and Innovation Act, drugs in this programme can be given an expedited review – and also benefit from an additional five years of market exclusivity. As these types of fungal infections are rare, the FDA also granted Cresemba orphan drug status.
“Today’s approval provides a new treatment option for patients with serious fungal infections and underscores the importance of having available safe and effective antifungal drugs,” says Edward Cox, who is director of the office of antimicrobial products in the FDA’s Center for Drug Evaluation and Research.
Cresemba is being co-developed with Astellas Pharma and the Swiss firm Basilea, which focusses on the development of innovative antibiotics, antifungals and oncology drugs. Basliea holds full global rights to Cresemba outside the US and Canada, where Astellas is the exclusive license holder. The approval means Astellas will pay Basilea a CHF 30 million (£20m) milestone payment.
“We’re pleased with the FDA’s approval of Cresemba for use in treating patients with these life-threatening infections,” says Bernie Zeiher, who is executive vice president of global development and therapeutic area head of infectious disease at Astellas. “We are proud to be able to offer a new treatment for patients in an area for which there is a significant unmet medical need.”
Professor Achim Kaufhold, Basilea’s chief medical officer, adds: “We anticipate completion of the review of Basilea’s European marketing authorisation application in the fourth quarter of 2015. In addition, in the second half of 2015 we expect top-line results from the ACTIVE Phase III study in invasive candidiasis – a potential further indication.”
Lilian Anekwe
Related Content
GSK’s Jemperli accepted for FDA review for endometrial cancer treatment
GSK has announced that the US Food and Drug Administration (FDA) has accepted its supplemental …
FDA approves ImmunityBio’s Anktiva bladder cancer treatment
ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, …
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
