Lowest in nearly three years! Up to 45 new drugs approved by FDA in 2019?

In recent years, the number of new drugs approved by the US FDA has increased significantly, reaching 62 in 2018, a record high However, statistics show that the number of new drugs approved by the agency is likely to decline this year By the end of June, the FDA had approved only 18 new drugs Analysis by vantage, a unit of evaluate, a pharmaceutical market research agency, shows that as of the end of 2019, only 27 new drug projects are waiting for FDA's review decision This also means that up to 45 new drugs are expected to be approved by FDA in 2019 Compared with the past few years, this is a slowdown to some extent, but certainly not the kind of recession that will cause industry panic From the end of 2018 to the beginning of 2019, several stops of the U.S government did have a certain impact on FDA's new drug approval In addition, the announcement of the resignation of Scott Gottlieb, the former director of FDA, triggered a shock in the biopharmaceutical stock market Scott Gottlieb is highly respected and has been promoting innovation and improving regulatory efficiency during his two years in office In the first half of this year, the number of new drug approvals and generic drug approvals dropped sharply The FDA said it was only a phased issue, which does not mean anything Industry observers expect new drug approval and generic approval to pick up in the second half of the year So far this year, the most eye-catching new drug approval is probably Novartis' zolgensma gene therapy It's not just a scientific breakthrough, it's also the most expensive drug in the world But as far as business potential is concerned, skyrizi is probably the most valuable new product on the market Seller analysts predict that skyrizi's annual sales will exceed $3 billion by 2024 Another drug of concern is Johnson & Johnson's balversa, the first FGFR kinase inhibitor for the treatment of urothelial cancer These targeted anticancer drugs received some attention at the ESMO conference last year and may represent an area that continues to receive industry attention So far, other new anticancer drugs worthy of attention include xpovio, the first nuclear output inhibitor of karyopharm company for the treatment of multiple refractory multiple myeloma, poly, a new CD79b targeted antibody drug conjugate of Roche for the treatment of diffuse large B-cell lymphoma, and piqray, the first PI3K inhibitor of Novartis for the treatment of breast cancer In the second half of the year, there are also some new drug reviews worthy of attention Golodirsen, Sarepta's second exon leap product for DMD, will be reviewed by FDA on August 19 The company's growing valuation reflects the value of its gene therapy program Luspatercept, one of Bristol Myers Squibb's key assets in the acquisition of new base, has been under review in the United States and the European Union On the FDA side, beta thalassemia applications are under priority review and are expected to receive a review decision on December 4, 2019; MDS applications are standard reviews and are expected to receive a review decision on April 4, 2020 Seller analysts predict that by 2024, the annual sales of luspatercept will exceed $1 billion and enter the list of heavyweight products In addition, enzyvant's new one-time tissue regeneration therapy rvt-802 is currently under priority review for the treatment of immune deficiency caused by congenital thymus free disease in rare pediatric diseases Rvt-802 is likely to be the first product of the roivant series founded by Vivek Ramaswamy, a legendary investor in biotechnology, to receive regulatory approval In addition, Roche's targeted anticancer drug entrectinib will have the opportunity to become the latest "cancer agnostic" broad-spectrum anticancer drug approved by the US FDA after Bayer and Loxo Oncology (acquired by Lilly) vitrakvi Reference source: new drug approvals head for a down year