Accelerated review, Sanofi and Regeneron spent US$67.5 million to purchase priority coupons

Source: chuminhua 2014-08-06: in order to beat competitors and get cholesterol lowering drug alirocumab on the market faster, Sanofi and regeneron, two companies, spent an unprecedented US $67.5 million on an FDA accelerated Review Certificate According to the Wall Street Journal, this accelerated review voucher was originally given to bio Marin pharmaceutical company, because it is used to reward companies that develop rare children's diseases according to the law issued in 2012 According to the policy, the company that obtains the accelerated review voucher can use another drug when seeking FDA approval to obtain the accelerated review status The company can also choose to sell this valuable accelerated review voucher to other companies This time, bio Marin did so It sold the accelerated review voucher in hand to Sanofi and regeneron, and earned $67.5 million Nancy Goodman, founder of kids V cancer, a patient group, said he hoped other companies could do the same with Sanofi and regeneron After his son died of brain cancer, Nancy Goodman founded kids V cancer and actively advocated the inclusion of the terms of this special voucher in the FDA safety and innovation act of 2012 For this transaction price, Goodman said that she had previously predicted between $25 million and $50 million, but in fact, biomarin received more money from the first accelerated review voucher than she had predicted She thinks the price will be higher in the future Goodman believes that in turn will stimulate pharmaceutical companies to develop deadly drugs for children's diseases, including testing the use of existing adult drugs for children She said she knew that two companies (which she declined to say) had drugs on hand that failed in adult clinical trials and now wanted to see if they could be used in children Goodman said, "but, you know, it's really not clear what the test results are Now that we know the value of the accelerated review coupon, I'm going to go back and contact the two companies and tell them, "look, here's a reason to continue studying."