FDA Approves Astellas’, Basilea’s Antifungal Drug

The US Food and Drug Administration (FDA) has approved Astella’s new drug application (NDA) for Cresemba (isavuconazonium sulfate), the prodrug for isavuconazole, to treat certain fungal infections. The drug was approved for patients 18 years of age and older for treating invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), which are rare, but serious infections. Aspergillosis is a fungal infection caused by the Aspergillus species, and mucormycosis is caused by the Mucorales fungi. These infections occur most often in people with weakened immune systems.

Astellas is co-developing Cresemba with Basilea Pharmaceutica International Ltd., a Swiss pharmaceutical company. Basilea holds full global rights to isavuconazole outside the US and Canada where Astellas is the exclusive license holder.Upon this approval, Astellas will pay a CHF 30 million ($30 million) milestone payment to Basilea Pharmaceutica International Ltd. under their license and co-development agreement.

Basilea submitted an European marketing authorization Application on July 16, 2014 for the treatment of invasive aspergillosis and mucormycosis in adults.

Cresemba belongs to a class of drugs called azole antifungal agents, which target the cell wall of a fungus. Cresemba is available in oral and intravenous formulations. Cresemba is the sixth approved antibacterial or antifungal drug product designated as a Qualified Infectious Disease Product (QIDP) by the FDA. This designation is given to antibacterial or antifungal drug products that treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of its QIDP designation, Cresemba was given priority review, which provides an expedited review of the drug's application. The QIDP designation also qualifies Cresemba for an additional five years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug, and Cosmetic Act. As these types of fungal infections are rare, the FDA also granted Cresemba orphan drug designations for invasive aspergillosis and invasive mucormycosis.

Earlier this year, the FDA approved the QIDP-designated drug, Actavis’s Avycaz (ceftazidime-avibactam), a new antibacterial drug product. Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor. The drug was approved to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.

In 2014, the FDA approved four QIDP-designated antibacterial drugs: Durata Therapeutics' Dalvance (dalbavancin) in May 2014; Cubist Pharmaceuticals' Sivextro (tedizolid phosphate) in June 2014; Cubist Pharmaceuticals Zerbaxa (ceftolozane/tazabactam) in December 2014; and The Medicines Company's Orbactiv (oritavancin) in August 2014. Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria such as Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. Actavis acquired Durata Therapeutics in 2014, and in December 2014, Merck & Co. agreed to acquire Cubist for $9.5 billion. Sivextro and Orbactiv are also approved to treat patients with ABSSSI caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. Zebrexa is indicated to treat adults with complicated intra-abdominal infections and complicated urinary tract infections.

Source: Astellas and Basilea Pharmaceutica

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