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New FDA drug approvals set a new record in 2018

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Wednesday, January 09, 2019

The Food and Drug Administration (FDA) set a new record in 2018 with the highest number of new drug approvals in the last two decades.

With 59 new molecular entities approved, 2018 represents a big departure from a disappointing 2016 when the FDA approved only 22 new drugs, the lowest number since 2010.

Oncology, haematology and infectious diseases are the main therapeutic areas with new drug approvals during 2018. The year also saw the approval of three different medications for the preventive treatment of migraines, and the approval of the first marijuana-derived drug.

The FDA also set a new record in orphan drug approvals in 2018, granting 86 new marketing authorizations for drugs treating rare diseases.

Under the leadership of the FDA Commissioner Scott Gottlieb, the agency has been making changes to facilitate the development of new drugs to treat rare diseases while limiting the potential abuse of some orphan drug incentives.

In 2017, the FDA launched a plan to modernize the Office of Orphan Products Development (OOPD) and eliminate a backlog in orphan drug designation requests. In addition to improving evaluation timelines, a recent report from the U.S. Government Accountability Office (GAO) also highlighted the need for the FDA reviewers to use more consistent criteria when reviewing orphan drug designation applications.

Orphan drug sales are projected to grow twice as fast as the rest of the pharmaceutical industry and to account for 20% of all prescription sales by 2024, according to a report by EvaluatePharma. Since the US Congress passed the Orphan Drug Act in 1983, the FDA has issued 760 orphan drug approvals.

Source: FDA
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