8. February 2012 15:45
The FDA has fast-tracked the New Drug Application (NDA) of Salix Pharmaceuticals’ Crofelemer for the control and relief of diarrhoea in people with HIV/AIDS on anti-retroviral therapy (ART).
The Priority Review designation is granted for treatments which are believed to offer major advances in treatments, or provide welcomed options where no adequate therapy exits.
Bill Forbes, Executive Vice President, Medical, Research and Development, and Chief Development Officer, Salix, says the review “signals” the belief the FDA has in the tablets.
Around half of the 1 million people in the US living with HIV/AIDS currently take an ART. Approximately 30% of these experience episodic or chronic diarrhoea.
Crofelemer is a first-in-class, gastrointestinal agent of botanical origin. Investigational studies support the use of the tablets as an anti-secretory, anti-diarrheal agent that may provide relief to patients through the inhibition of chloride secretion by both gut CFTR (Cystic Fibrosis Transmembrane Conductance Regulator Protein) as well as gut CaCC (calcium-activated chloride channel).
“We are pleased with the FDA’s acceptance of the NDA for Crofelemer and their decision to grant Priority Review for our application,” said Bill Forbes. “We believe the availability of Crofelemer has the potential to change the treatment paradigm for HIV/AIDS patients suffering from diarrhoea.”
An action date of June 5th 2012 has now been set for the Priority Review.
The North Carolina-based company develops and markets prescription products for the treatment of gastrointestinal diseases.
19. August 2011 11:20
The CHMP has accepted to review the application from Merck and ARIAD Pharmaceuticals for ridaforolimus, an investigational oral mTOR inhibitor.
The inhibitor has been developed for the treatment of metastatic soft-tissue or bone sarcomas in patients who have responded well to chemotherapy.
Marty Duvall, Senior Vice President and General Manager, Merck Global Human Health, says the review is an “important milestone” for the potential treatment option.
Within the next two months, the FDA will determine whether it will accept a similar application submitted by Merck.
“We are pleased with both the acceptance of the MAA in Europe and the timely filing of the NDA for ridaforolimus in the United States,” said Harvey Berger, Managing Director, Chairman and CEO of ARIAD.