Company

Product

Description

Indication

Status

Akari Therapeutics Inc., of New York

Nomacopan

C5 complement inhibitor

Bullous pemphigoid

FDA granted orphan designation

Amgen Inc., of Thousand Oaks, Calif.

AMG-397

Selective MCL-1 inhibitor

Relapsed or refractory hematological malignancies

Phase I dose-escalation trial placed on clinical hold to evaluate safety signal for cardiac toxicity; Amgen also placed voluntary hold on new enrollment for phase I testing another MCL-1 inhibitor, AMG-176, in multiple myeloma

Ardelyx Inc., of Fremont, Calif.

Ibsrela (tenapanor)

Small-molecule inhibitor of sodium-hydrogen exchanger NHE3

Irritable bowel syndrome with constipation

Approved by FDA as 50-mg, twice-daily oral pill for use in adults

Auris Medical Holding Ltd., of Hamilton, Bermuda

Keyzilen (AM-101)

Small-molecule NMDA receptor antagonist formulated in biocompatible gel for intratympanic administration

Tinnitus

Obtained advice from FDA and EMA, in which agencies supported use of Tinnitus Functional Index questionnaire as primary outcome measure for phase II/III trial; agencies also agreed on less frequent collection of patient-reported tinnitus loudness than in previous trials, where daily ratings turned out to be problematic; FDA considers improvement in tinnitus loudness to be co-primary endpoint, whereas EMA endorsed it as secondary endpoint; both agencies endorsed sample size for trial

Glaxosmithkline plc, of London

Nucala (mepolizumab)

Monoclonal antibody targeting IL-5

Severe eosinophilic asthma

FDA expanded approval for use in children, ages 6 to 11


Notes

For more information about individual companies and/or products, see Cortellis.

 

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