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35 new drugs, FDA new drug approvals hit a new high

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Industry News
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Release time:
2020/10/27 10:37
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[Abstract]:

The FDA recently announced that in the 2012 fiscal year ended September 30 this year, the FDA approved a total of 35 new drugs-31 of which were listed as new molecular entities (NMEs). This data is the same as the previous fiscal year and is one of the highest levels since 2004. In 2004, 36 new drugs were approved. In the following years, this number dropped to more than half of current levels.
Small biological companies take the lead
     Among the new drugs approved in the 2012 fiscal year, there are 10 anti-cancer drugs, including the first drug used to treat basal cell carcinoma of the skin; drugs used to treat HIV and macular degeneration; a meningitis vaccine and the first Drugs targeting the genetic basis of cystic fibrosis (CF). Two weight-loss drugs were also approved for sale in 2012, which was the first batch of such products approved in more than a decade. However, one of the products (Qsymia produced by Vivus) is not classified as NME because it contains two previously approved active ingredients. There are also 9 new drugs used to treat rare diseases, which affect a small proportion of the population.
     According to the FDA, the number of new drugs approved by small biotech companies is “notable”, including drugs used by Vertex Pharmaceuticals to treat CF patients with specific genetic mutations, and Xtandi (enzalutamide), a prostate cancer treatment drug developed by Medivation. Among the major pharmaceutical companies, Bayer, Roche, Pfizer and Sanofi also have new anti-cancer drugs approved this year.
     Experts in the pharmaceutical industry hope that the continued momentum for new drugs to be approved shows that pharmaceutical companies are coming out of the dilemma of a severe lack of innovation in the past decade. Since approved drugs often reflect the number of applications submitted by pharmaceutical companies in the previous year, the report may indicate that the pharmaceutical industry has become healthier and more productive.
Strong innovation momentum
     At the "Forbes Healthcare Summit" in New York, four senior executives in charge of R&D in the pharmaceutical industry talked about the industry's innovation trends. Biogen CEO George Scangos pointed out that although new drug inventions have been increasingly expensive over the years, the average development cost of new drugs seems to have flattened for the first time in the past few decades. Several other executives at Johnson & Johnson, Pfizer and Onyx Pharmaceuticals all believe that after a long period of lack of innovation, the situation in the pharmaceutical industry may be turning around.
     However, most of the rebound in the number of new drugs approved in recent years should be attributed to the FDA itself. Under the leadership of Commissioner Margaret Hamburg (MargaretHamburg), the FDA has worked more closely with pharmaceutical companies to simplify the approval process, especially in the treatment of cancer and other rare diseases. Among the breakthrough new drugs approved this year, there is the first drug in history that targets the genetic basis of CF, developed by Vertex Pharmaceuticals; a drug developed by Roche is for skin basal cell carcinoma; and Stribild is developed by Gilead Pharmaceuticals A new combination drug developed to treat HIV.
     The FDA provided evidence that, in general, it is faster in reviewing new drugs than other countries, and it does so in accordance with the timetable set by the law. This law requires pharmaceutical companies to pay user fees for prescription drugs in order to provide funds for regulatory agencies to review their drugs. The report states that most drugs are approved by the FDA for use in American patients before approval in other countries, and the efficiency of the drug review process continues to improve. Indeed, of the 32 drugs that have also been approved by other countries, 24 were first approved in the United States. About 77% of the drugs were approved during the first round of FDA review. The FDA did not require additional research data. Otherwise, This will reduce the speed of approval of new drugs.