March 24, 2020

Impact: Moderate

FDA has announced that it will postpone or cancel all non-essential meetings through April 30, 2020 due to COVID-19. The following meetings are affected:

  • April 21, 2020: FDA Pulmonary-Allergy Drugs AdCom to discuss Trelegy Ellipta sNDA for IMPACT trial results (GlaxoSmithKline).
  • April 22, 2020: FDA AdCom (undetermined) to discuss sNDA for OCA (Ocaliva) in liver fibrosis due to NASH (Intercept).
  • April 23, 2020: FDA imaging Drugs AdCom to discuss NDA for flortaucipir F18, radioactive diagnostic agent for Alzheimer’s disease (Ely Lilly).

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March 20, 2020

Impact: High

Regeneron and Sanofi have announced the initiation of a U.S. phase 2/3 trial evaluating anti-IL6 mAb Kevzara (sarilumab) in patients hospitalized with severe COVID-19 infection, to begin at medical centers in New York.

The adaptive design trial is expected to enroll up to 400 patients. The first part will evaluate the impact of Kevzara on fever and need for supplemental oxygen and the second part will evaluate the improvement in longer-term outcomes (preventing death, reducing the need for medical ventilation, supplemental oxygen and/or hospitalization).

Patients will be randomized 2:2:1 into Kevzara high dose, Kevzara low dose and placebo. The primary endpoint is reduction of fever and the secondary endpoint is decreased need for supplemental oxygen.

Trials outside the U.S. are expected to rapidly initiate, including in most affected areas such as Italy.

The restructuring of the Kevzara collaboration between the two companies is expected to be finalized in 1Q2020 as they continue to collaborate on COVID-19, with Regeneron leading U.S. work and Sanofi leading ex-U.S. work.

IL6 may play a role in driving the overactive inflammatory response in the lungs of COVID-19 patients and this is the first controlled U.S. trial to evaluate the effect of this cytokine inhibition.

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With conventions and other events are taking precautions amid the COVID-19 outbreak, some conferences are postponing, while others are providing virtual-only access. Companies are restricting travel for employees, preventing conference attendance. Speakers are unable to attend conventions as many leading academic institutions have restricted physician travel for months. Read more