trending Market Intelligence /marketintelligence/en/news-insights/trending/wmmtcxlolxwbmogdxlweba2 content esgSubNav
In This List

Fitch: New drug approvals slow YOY in US

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


Fitch: New drug approvals slow YOY in US

The U.S. Food and Drug Administration approved 44% fewer new drugs through April, compared to the same period in 2017, according to a report by Fitch Ratings.

The rating agency said the FDA cleared 10 new molecular entities, or NMEs, in the first four months of 2018, while it approved 18 in the year-ago period.

Of the 2018 approvals, 30% were for biologics, compared to 28% the prior year. The percentage of biologics approvals remained relatively steady since 2014, ranging from 27% to 33%, Fitch director Bob Kirby said.

Biologics are drugs whose active components are naturally sourced, instead of chemically synthesized.

There have been eight priority review NME approvals for year-to-date 2018, one less than the nine recorded during the same period last year. During 2017, priority NME approvals made up 27 of the total of 46, compared to 14 out of 21 in 2016.

Fitch Ratings said 30% of the novel medicines approved through April were cancer drugs and 20% were HIV therapies. According to the report, Merck & Co. Inc.'s Keytruda and Bristol-Myers Squibb Co.'s Opdivo continue to produce significant clinical trial data for various types of tumors. Alzheimer's disease treatments remain elusive, the report noted.