Company

Product

Description

Indication

Status

Phase III

Amgen Inc., of Thousand Oaks, Calif.; Allergan plc, of Dublin

ABP-798

Biosimilar candidate to Rituxan (rituximab, Roche Holding AG / Biogen Inc.)

CD20-positive B-cell non-Hodgkinlymphoma

Primary endpoint, an assessment of overall response rate by week 28, was within the prespecified margin for ABP-798 compared to Rituxan, showing clinical equivalence; safety and immunogenicity were comparable

Retrophin Inc., of San Diego

Fosmetpantotenate

Small-molecule replacement therapy designed to pass the blood-brain barrier and be converted to phosphopantothenate

Pantothenate kinase-associated neurodegeneration

Missed primary and secondary endpoints as compared to placebo

Satsuma Pharmaceuticals Inc., of San Francisco

STS-101

Dihydroergotamine (DHE) nasal powder

Migraine

Dosed the first patient in its EMERGE efficacy trial for the acute treatment of migraine; the study will involve approximately 1,140 migraine patients in the U.S. with participants randomized (1:1:1) to receive 1 of 3 treatments: STS-101 DHE 3.9 mg, STS-101 DHE 5.2 mg or matching placebo and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication; top-line data is expected in the second half of 2020

Viiv Healthcare Ltd., of London

Cabotegravir and rilpivirine (Edurant, Johnson & Johnson) combination

HIV-1 integrase strand transfer inhibitor; non-nucleoside reverse transcriptase inhibitor

HIV-1 infection in patients whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine

Met the primary endpoint, showing that the long-acting regimen of cabotegravir and rilpivirine, injected every two months, was non-inferior to cabotegravir and rilpivirine administered every month at week 48


Notes

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