Astellas wins FDA orphan drug status for approved antifungal Cresemba

Following approval for the antifungal therapy from the US Food and Drug Administration (FDA) in December 2023, Astellas’ Cresemba (isavuconazonium sulfate) has gained FDA orphan drug exclusivity and pediatric market exclusivity for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM).

Cresemba being the first FDA-approved medication for the treatment of IA and IM, Astellas has gained orphan drug exclusivity that grants the drug seven years of US market exclusivity in its approved indication. The auxiliary pediatric exclusivity gives Cresemba an additional six months of protection, as per the 11 March press announcement.

On 8 December 2023, the injectable Cresemba was awarded FDA approval as a treatment for IA and IM patients aged one or older.  A separate capsule formulation of the drug is indicated to treat patients ages six and older, weighing at least 16kg.

The consensus from GlobalData, the parent company of Pharmaceutical Technology, forecasts predict that Cresemba will generate $450m in 2023.

The FDA approval was granted based on data from two paediatric clinical studies, one of which was a Phase II trial (NCT03816176) evaluating patients aged between one to 17 years. The non-randomised, open-label, single-group assignment Phase II study assessed drug efficacy, safety and pharmacokinetics in 31 paediatric patients.

As per the Centers for Disease Control and Prevention (CDC), IA occurs predominantly in immunocompromised populations when the aspergillus fungus gives rise to serious infections. IM is a rare fungal infection caused by environmental moulds called mucormycetes.

“Astellas recognises the importance of addressing significant unmet medical needs, especially for pediatric patients with rare and potentially life-threatening IA and IM infections,” said Laura Kovanda, PhD, executive director at Astellas.

Sign up for our daily news round-up!

Give your business an edge with our leading industry insights.