Company

Product

Description

Indication

Status

Abbvie Inc., of North Chicago

Mavyret (glecaprevir and pibrentasvir) tablets

HCV NS3/4A protease inhibitor and HCV NS5A inhibitor

Chronic hepatitis C virus

FDA expanded approval for 8-week treatment in treatment-naive adults and children, 12 and older and weighing at least 99 pounds, who have genotypes 1, 2, 3, 4, 5 or 6, as well as compensated cirrhosis

Acacia Pharma Group plc, of Cambridge, U.K.

Barhemsys (amisulpride injection)

Binds to dopamine D2/3 receptors

Postoperative nausea and vomiting

FDA accepted resubmitted NDA, classifying resubmission as class 2; PDUFA date is Feb. 26, 2020

Biomarin Pharmaceutical Inc., of San Rafael, Calif.

BMN-307

AAV5-phenylalanine hydroxylase gene therapy

Phenylketonuria

Submitted clinical trial application with U.K. Medicines and Healthcare products Regulatory Agency for phase I/II trial

Genmab A/S, of Copenhagen, and Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson

Darzalex (daratumumab)

CD38-targeted monoclonal antibody

Multiple myeloma

FDA approved use in combination with bortezomib, thalidomide and dexamethasone in patients newly diagnosed who are eligible for autologous stem cell transplant

Inventiva SA, of Daix, France

Lanifibranor

Small-molecule PPAR activator

Nonalcoholic steatohepatitis

FDA granted fast track designation

Ipsen SA, of Cambridge, Mass.

Dysport (abobotulinumtoxinA)

Botulinum toxin

Upper limb spasticity

FDA expanded use in children, 2 and older, excluding spasticity caused by cerebral palsy

Theratechnologies Inc., of Montreal

Trogarzo (ibalizumab)

CD4-directed post-attachment HIV-1 inhibitor

HIV-1

Approved by European Commission for use in combination with other antiretrovirals in adults infected with multidrug-resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen

Zogenix Inc., of Emeryville, Calif.

Fintepla (ZX-008)

Fenfluramine

Seizures associated with Dravet syndrome

Resubmitted NDA

Notes

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

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