10. May 2012 14:39
The FDA and the EMA are to review Biogen Idec’s marketing application for BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis (MS).
BG-12 is the only known investigational compound for the treatment of MS that has experimentally demonstrated activation of the Nrf-2 pathway.
It has demonstrated significant reductions in MS disease activity, coupled with favourable safety and tolerability in two separate Phase III clinical trials.
Last year, Biogen published data from the DEFINE and CONFIRM global clinical trials that demonstrated BG-12’s effectiveness in patients taking the treatment either twice or three times a day over a period of two years.
As a result, the FDA has now accepted Biogen’s New Drug Application and granted the company a standard review timeline. In addition, the EMA has validated a similar application for review.
10. April 2012 11:59
The FDA has granted Fast Track designation to EpiCept’s neuropathic pain relief treatment AmiKet (amitriptyline 4%, ketamine 2% cream) for patients previously treated with taxane-based chemotherapy.
AmiKet is a topical analgesic cream designed to provide pain relief associated with chemotherapy-induced peripheral neuropathy which has demonstrated efficacy and safety in clinical trials.
Jack Talley, EpiCept President and CEO, says the designation by the US health regulator is “confirmation of the pressing need for therapies to treat neuropathic pain associated with CIPN”.
It is estimated there are currently more than 15 million people in the US alone who suffer from neuropathic pain.
The FDA’s Fast Track Program is designated to facilitate the review of new treatments used to treat serious or life-threatening conditions and address unmet medical needs. The Agency says the scheme may reduce review periods by half.
The New York-based company recently confirmed the engagement with SunTrust Robinson Humphrey to assist in the exploration of strategic alternatives to maximise the commercial opportunities of AmiKet.
It now hopes the FDA’s decision will increase interest in the cream. “We expect the receipt of this designation will prove to be highly valuable in our current partnering efforts for AmiKet,” said Jack Talley.
2. March 2012 12:36
The FDA has delayed making a decision on whether to approve the use of Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
Further data supplied by Pfizer and Bristol-Myers Squibb on patient trials after the original application will take an additional three months to review, the Agency has said.
Pfizer and BMS said in a joint statement they will continue to work closely with FDA during the review period.
Eliquis is not yet approved in any country for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
It faces competition from Boehringer’s Pradaxa (dabigatran) and J&J’s Xarelto (rivaroxaban) for the indication.
Industry analysts predict all three have the potential to become ‘blockbuster’ brands as doctors and patients search for an alternative to warfarin.
Eliquis was approved in May 2011 by the European Union as a treatment option for the prevention of blood clots in patients who have undergone hip or knee replacement surgery.
BernsteinResearch analyst Dr Timothy Anderson forecasts total sales of Eliquis to reach $395 million this year, rising to $2.5 billion in 2015 and $3.7 billion by 2020.