In 2018, 53 new drugs have been approved by the FDA. These 5 have the most commercial potential

According to the data recently released by EP vantage under evaluatepharma, a pharmaceutical market research institution, in 2017, the US FDA approved 57 new drugs, the largest number of new drugs in the past five years So far in 2018, the FDA has approved 53 new drugs In the six weeks to the end of the year, as many as 11 drugs will face the FDA's review decision This also means that in 2018, the number of new drugs approved by FDA is bound to reach a new high 2018, FDA's "decision to kill" EP Vantage pointed out that in 2018, the FDA made positive decisions on some high-profile and high-risk projects, among which some of the most important projects for drug developers include GW pharmaceutical's world's first plant-based cannabiole (cannabidiol), Alnylam's world's first RNAi drug, onpatter (paisiran), and array Mektovi (encorafenib), the company's MEK inhibitor for melanoma However, some new drug programs are not so lucky, such as Ionis's antisense RNA drug waylivra (volanesorsen), which has been supported by the FDA Expert Committee in the early stage for the treatment of family chylomicronemia syndrome (FCS), but was finally rejected by the FDA Overall, however, the fact that smaller companies in the industry have been able to win FDA approval in the past few years does boost their biotech valuations If there is any message from the current number of new drug approvals, it is that confidence in a healthy regulatory environment should continue According to the analysis of EP vantage, in 2018, the most potential new drug approved by FDA is biktarvy, a three in one HIV compound drug from Gilead, whose expected success will largely depend on Gilead's existing franchise In 2019, the category of anti CGRP migraine drugs will be more closely watched by the industry In 2018, FDA has approved three anti CGRP migraine drugs from Amgen / Novartis, Lilly and TIWA The combined sales volume of these three drugs in the fifth year after their listing in the U.S market is expected to be $2.8 billion However, there are some disputes in the industry about whether these preventive therapies can meet the expectations Discussion Although the number of new drugs approved in 2018 has not yet been finalized, for those drugs that have entered the market, according to optimistic estimates of industry analysts, the total sales potential in the fifth year of the U.S market is expected to be $21 billion Considering that there are many new drugs waiting to be approved, and from the historical data, this number is actually a very low number What else to look forward to in the next six weeks? According to the target date of PDUFA, in the remaining six weeks of 2018, there are still some drugs waiting for FDA's review results, the most striking of which are listed below, including Bayer and loxooncology's "broad spectrum" targeted anticancer drug larotrecinib and catalyst's rare disease drug firdapse Similarly, FDA's review decisions are critical for small pharmaceutical companies involved in these drugs Even at this stage, it is difficult to accurately predict the final number of new molecular entities (NME) approved by FDA in 2018, because some new drug projects may not pass the approval, on the other hand, FDA may also approve some new drug projects with PDUFA date of 2019 in advance It is worth noting that vantage's NME includes new molecules approved by two FDA agencies, drug review and Research Center (CDER) and biological product approval and Research Center (CBER) In fact, the exact number of approvals is irrelevant, and what matters is the long-term trend, which clearly reflects the attitude of regulators Many industry analysts believe that in the past few years, FDA has been trying to promote progress in the field of biotechnology, which should not change much in 2019 (compiled by Sina pharmaceutical / newborn)