FDA's recent spate of 'surprising' rejections prompt concerns - Cowen

Tricida

26/08/2020 12:31

** U.S. health regulator's recent spate of decisions to
decline approvals to some drugs prompt concerns that the
functioning of the U.S. FDA and its communication with sponsors
is not as good as it has been in the recent past due to
COVID-19, brokerage Cowen says, citing a FDA consultant from
Prevision Policy
    ** The agency this month declined to approve Gilead Sciences
Inc's  GILD.O  rheumatoid arthritis treatment filgotinib,
Tricida Inc's  TCDA.O  kidney disease drug veverimer and
BioMarin's  BMRN.O  gene therapy for hemophilia A  urn:newsml:reuters.com:*:nL4N2FQ39Z
 urn:newsml:reuters.com:*:nL4N2FL2SW  urn:newsml:reuters.com:*:nL4N2FL2V0
    ** Though seemingly a trend, it is possible that the cluster
is a coincidence, brokerage also notes
    ** Though it is not clear that the efficiency of the agency
has declined, there are factors that could be reasonably
anticipated to disrupt its normal activities and make the
approval process a bit more fraught for sponsors - Cowen
    ** Prevision thinks it is also possible that the rejections
could reflect a reluctance at the reviewer level to push the
boundaries of the FDA's accelerated approval pathway in the face
of outside criticism and leadership changes at the agency,
brokerage says

 (Reporting by Manojna Maddipatla in Bengaluru)
 ((manojna.kalyani@thomsonreuters.com; within the U.S. +1 646
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