Nile Therapeutics heart drug fast-tracked

The US Food and Drug Administration (FDA) has awarded fast-track status to Nile Therapeutics' development programme for cenderitide aimed at reducing mortality after heart failure. The novel indication is being referred to as "post-acute", according to the company. 

Specifically, Nile is developing the drug to reduce cardiovascular mortality and cardiovascular re-hospitalisation in the post-acute period in patients with acute decompensated heart failure. 

Nile plans to develop cenderitide as an outpatient therapy to be delivered continuously through a subcutaneous pump for up to 90 days after discharge from the hospital. The company said it believes the drug will provide patients with sustained symptomatic relief that could significantly reduce post-acute re-hospitalisations.

Fast-track status, which is reserved for drugs that have the potential to treat serious diseases and fill unmet medical needs, allows for a rolling submission and review of the marketing application, as well as more frequent feedback from the FDA.

Cenderitide, Nile's lead product, is a novel rationally designed chimeric peptide that was created by scientists at the Mayo Clinic.