The US Food and Drug Administration has approved the first monoclonal antibody (mAb) to prevent hereditary angioedema (HEA) attacks. Dublin-based Shire was given the go-ahead in August to market Takhzyro (lanadelumab) as prophylactic treatment for HEA types I and II in patients aged 12 years or older. HEA is a rare but life-threatening genetic disease caused by mutations in the C1 esterase inhibitor gene, which leads to an overactivation of the complement system. This can trigger unpredictable bouts of subcutaneous or submucosal swelling anywhere in the body, potentially leading to blocked airways, and in…
FDA new drug approvals in Q3 2018
With one full quarter still to go before the end of the year, 41 novel drugs have already been approved by the FDA, putting 2018 on track to surpass 1996’s record 53 new drug approvals. Many of the 21 products approved in Q3 Fonte: NATURE REVIEWS | DRUG DISCOVERY VOLUME 17 | NOVEMBER 2018 | 779 Click here to original publication.…
How much do phase III trials cost?
Drug development has been estimated to cost anywhere from US$43 million on one controversial end of the spectrum to $2.9 billion on the other when failures, post-approval studies and opportunity cost are factored in… Fonte: NATURE REVIEWS | DRUG DISCOVERY VOLUME 17 | NOVEMBER 2018 | 777 Para acessar a publicação na íntegra clique aqui …