FDA grants Fast Track designation to Nile’s cenderitide
SAN MATEO, Calif.—Biopharmaceutical company Nile Therapeutics, Inc. announced today that the U.S. Food and Drug Administration has granted its post-acute development program for cenderitide with Fast Track designation. The program’s goal is to reduce cardiovascular mortality and cardiovascular re-hospitalization in the post-acute period among patients suffering from acute decompensated heart failure. Nile’s plan is to develop cenderitide as an outpatient therapy for acutely decompensated heart failure (ADHF) patients. The therapy would be delivered continuously for up to 90 days following a patient’s discharge from the hospital, a novel therapeutic indication that is referred to as “post-acute.”
“We are very pleased that the FDA has recognized cenderitide's potential to address an important unmet medical need for heart failure patients,” says Joshua Kazam, Nile's Chief Executive Officer.
The FDA reserves the Fast Track designation for products that have demonstrated potential in addressing unmet medical needs for serious or life-threatening conditions, and the process is intended to assist in the development and expedite the review of those products. Drugs that receive Fast Track designation have the option of submitting sections of the New Drug Application (NDA) for review as they are completed, whereas normally, NDA review doesn’t begin until the entire application has been submitted. Additionally, a drug with Fast Track designation can be considered for Priority Review, which can reduce the NDA review time from ten months to six months.
According to the FDA website, Fast Track designation and Priority Review “do not compromise the standards for the safety and effectiveness of the drugs that become available through this process.” The FDA also asserts that the new review approaches “have yielded tangible results in bringing safe and effective drugs to patients with serious diseases more quickly.” Applying for Fast Track designation is up to a drug company, and reflects their belief in their product’s ability to either surpass current treatment options or offer options for unmet medical needs, as is the case with Nile’s cenderitide program.
Cenderitide currently holds most of Nile’s focus, in keeping with their cardiovascular leanings, and falls into the category of drugs called natriuretic peptides. Preclinical and clinical data on the natriuretic peptide have shown that the peptides can act on multiple disease processes that contribute to the negatives outcomes that go along with heart failure. Two natriuretic peptides are already on the market for the treatment of ADHF, Natrecor in the United States and hANP in Japan.
Clinical results so far have shown that cenderitide might be a superior treatment solution thanks to the therapeutic benefits it offers, including reduction in cardiac pressure, preservation/enhancement of renal function, improved diuresis and managed blood pressure reduction. A short-term infusion of cenderitide has demonstrated positive effects on patients’ cardiovascular and renal parameters, and Nile feels that continuous and extended infusions through a subcutaneous pump could provide sustained symptomatic relief, contributing to fewer post-acute hospitalizations and continued improvement in cardio-renal functions.
Hospitalization during the post-acute period, 90 days after admission for ADHF, is a substantial issue, as the American Heart Association notes that there are more than 1.2 million ADHF admissions per year in the United States and 40 percent of those patients return to the hospital. It is expected that cenderitide will improve post-acute re-hospitalization in the following ways:
* Prolonged reduction of wedge pressure and blood pressure
* Additional diuretic and natriuretic effects on top of standard oral diuretics
* Improved medication compliance with a continuous subcutaneous pump delivery
* Possible prevention of the progression of maladaptive ventricular hypertrophy
* Suppression of cardiac fibroblast proliferation and a reduction in scarring
Nile has plans for a Phase I clinical trial in the second quarter of 2011 to assess the pharmacokinetics and pharmacodynamics of cenderitide when delivered via a subcutaneous pump, and expects the trial to be complete by the first quarter of 2012.
“If our post-acute cenderitide program is successful, then we may be able to reduce the annual number of hospital visits for ADHF, potentially saving the health care system billions of dollars,” says Kazam.