Company

Product

Description

Indication

Status

Aerie Pharmaceuticals Inc., of Durham, N.C.

Rhokiinsa (netarsudil ophthalmic solution)

Rho kinase inhibitor

Elevated intraocular pressure in primary open-angle glaucoma or ocular hypertension

EMA's Committee for Medicinal Products for Human Use recommended marketing authorization

Astellas Pharma Inc., of Tokyo, and Fibrogen Inc., of San Francisco

Evrenzo (roxadustat)

Inhibitor of hypoxia-inducible factor prolyl hydroxylase

Anemia associated with chronic kidney disease in dialysis patients

Approved by Japan's Ministry of Health, Labour and Welfare

Astellas Pharma Inc., of Tokyo

Xospata (gilteritinib)

Small-molecule FLT3 inhibitor

Relapsed or refractory acute myeloid leukemia

EMA's Committee for Medicinal Products for Human Use recommended approval as a monotherapy in patients with FLT3 mutation

Eli Lilly and Co., of Indianapolis

Trulicity (dulaglutide)

Targets GLP-1

Type 2 diabetes

EMA's Committee for Medicinal Products for Human Use recommended update to label to include results from Rewind cardiovascular outcomes trial, which achieved significant 12% risk reduction in major adverse cardiovascular events

EMD Serono, part of Merck KGaA, of Darmstadt, Germany

Bavencio (avelumab)

Anti-PD-L1 antibody

Advanced renal cell carcinoma

EMA's Committee for Medicinal Products for Human Use recommended approval for use in combination with axitinib for first-line treatment

Emmaus Life Sciences Inc., of Torrance, Calif.

Xyndari (glutamine)

Amino acid

Sickle cell disease

Withdrew marketing authorization application to EMA; Committee for Medicinal Products for Human Use has maintained initial opinion that MAA did not demonstrate Xyndari to be effective at reducing the number of sickle cell disease crises or hospital visits

Hovione LLC, of East Windsor, N.J.

HY-01

Topical minocycline gel 3%

Moderate to severe inflammatory rosacea

Received guidance at end-of-phase II meeting with FDA for design and clinical endpoints for phase III trial; 2 pivotal studies will enroll 750 patients each, with primary endpoints of absolute reduction in inflammatory lesions at week 12 vs. baseline and achievement of "clear" or "almost clear" and 2-grade reduction on Investigator Global Assessment

Merck & Co. Inc., of Kenilworth, N.J.

Pifeltro (doravirine 100 mg)

Non-nucleoside reverse transcriptase inhibitor

HIV-1

FDA expanded indications to include adults with HIV-1 infection who are virologically suppressed on a stable antiviral regimen with no history of treatment failure and no known substitutions associated with resistance to Pifeltro

Merck & Co. Inc., of Kenilworth, N.J.

Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate)

Fixed-dose antiretroviral combination tablet

HIV-1

FDA expanded indications to include adults with HIV-1 infection who are virologically suppressed on a stable antiviral regimen with no history of treatment failure and no known substitutions associated with resistance to individual components of Delstrigo

Newron Pharmaceuticals SpA, of Milan, Italy, Meiji Seika Pharma Co. Ltd., of Tokyo, and Eisai Co. Ltd., also of Tokyo

Equfina tablets (safinamide mesylate)

Selective monoamine oxidase B inhibitor

Parkinson's disease

Approved in Japan to treat wearing-off phenomenon in patients with Parkinson's under treatment with drug containing levodopa

Novo Nordisk A/S, of Bagsvaerd, Denmark

Rybelsus (semaglutide)

Oral GLP-1 receptor drug

Type 2 diabetes

Approved by FDA to improve control of blood sugar in adults, along with diet and exercise

Reneo Pharma-ceuticals Inc., of San Diego

REN-001

Selective PPAR-delta agonist

Fatty acid oxidation disorders

FDA granted orphan designation

Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y.

Dupixent (dupilumab)

IL-4/IL-13 inhibitor

Severe chronic rhinosinusitis with nasal polyps

EMA's Committee for Medicinal Products for Human Use recommended expanding approval to treat adults with CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control


Notes

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

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