0305 Modality approvals
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Product Development

The pace of new modality approvals is picking up

Close to 30 new modality drugs approved in the last five years, and about 50 in registrational trials

New modalities are broadening their footprint, with close to 30 new modality drugs approved in the last five years, and about 50 in registrational trials.

Mar 6, 2021 | 2:35 AM GMT

Last week’s FDA approval of Sarepta’s Amondys 45 marks the ninth new modality drug to be approved in the last year, a sign that the pace of new therapeutic formats making it to market is reaching a trot, if not yet a gallop. Despite the hurdles, the regulatory breakthroughs and deep late-stage pipeline indicate that new modality therapies are finally creating a heavy footprint in drug development.

Six major classes of drugs outside small molecules and standard mAbs have products on the market, with all but one seeing an approval in the last year. The outlier, bispecific antibodies, could see an approval in the next few months — mivantamab from Johnson & Johnson (NYSE:JNJ) and Genmab A/S (NASDAQ:GMAB; CSE:GMAB) is under review at FDA.

Regulatory approvals of new modality therapeutics (below, filled circles) show the years put into developing next-generation modalities are starting to pay off. Another six compounds (open circles) are under review in the U.S. or Europe, with a decision expected this year. Behind them lie almost 50 molecules in registration, Phase III or pivotal Phase II testing.

All but three of the 33 new modality drugs approved, and still on the market, in the U.S., Europe or Japan were approved in the last

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