Please login to the form below

Not currently logged in
Email:
Password:

Nile Therapeutics heart drug fast-tracked

The US Food and Drug Administration (FDA) has awarded fast-track status to Nile Therapeutics' development programme for heart drug cenderitide
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. 

31st March 2011

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
M&F Health

M&F Health is a full service communications agency, dedicated to the health and wellbeing sector. We are an independent amongst...

Latest intelligence

patients
Retaining reader value in plain language summaries of clinical studies
Balancing the risk of misinterpretation with the public’s ability to understand simplified plain-language summaries...
Can we talk about the ego-bias and chemicals influencing your target audience’s behaviour?
Over the Summer, the Page & Page team became fascinated by two books on this very subject. Two books from one author, Dean Burnett, an eminent neuroscientist, lecturing at Cardiff...
Paris
Making Europe a leader in bioscience: boosting trust and opening minds
A vision of Paris as Europe's leading hub for life sciences innovation...

Infographics