Company Product Description Indication Status

Agile Therapeutics Inc., of Princeton, N.J.

Twirla (levonorgestrel/ethinyl estradiol)

Transdermal system containing progestin and estrogen

Contraception

FDA extended PDUFA date by 3 months to Feb. 16, 2020

Amarin Corp. plc, of Dublin

Vascepa (icosapent ethyl)

Ethyl eicosapentaenoic acid

Cardiovascular disease

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 to recommend approval expanding indication and label to reduce the risk of cardiovascular events in high-risk patients based on results from Reduce-IT cardiovascular outcomes trial

Astrazeneca plc, of Cambridge, U.K.

Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin)

Once-daily formulation comprising metformin, DPP-4 inhibitor and SGLT2 inhibitor

Type 2 diabetes

Approved by European Commission for use in adults to improve glycemic control

Beigene Inc., of Beijing

Brukinsa (zanubrutinib)

BTK inhibitor

Mantle cell lymphoma

Approved by FDA for use in adults who have received at least 1 prior therapy

Celgene Corp., of Summit, N.J.

Revlimid (lenalidomide)

Immunomodulatory agent

Follicular lymphoma

EMA's Committee for Medicinal Products for Human Use recommended approval in combination with rituximab for adults with previously treated disease

Jazz Pharmaceuticals plc, of Dublin

Solriamfetol

Dual-acting dopamine and norepinephrine reuptake inhibitor

Narcolepsy

EMA's Committee for Medicinal Products for Human Use recommended approval to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure

Novartis AG, of Basel, Switzerland

Mayzent (siponimod)

Small-molecule agonist of S1P receptors S1P1 and S1P5

Secondary progressive multiple sclerosis

EMA's Committee for Medicinal Products for Human Use recommended approval for use in patients with active disease evidenced by relapses or imaging features of inflammatory activity

Rigel Pharmaceuticals Inc., of South San Francisco

Fostamatinib

SYK inhibitor

Chronic immune thrombocytopenia

EMA's Committee for Medicinal Products for Human Use recommended approval for use in adults who are refractory to other treatments

Recordati SpA, of Milan, Italy

Isturisa (osilodrostat)

Inhibits 11-beta-hydroxylase

Endogenous Cushing's syndrome

EMA's Committee for Medicinal Products for Human Use recommended approval for use in adults

Roche Holding AG, of Basel, Switzerland

Kadcyla (trastuzumab emtansine)

HER2-targeting antibody-drug conjugate

Breast cancer

EMA's Committee for Medicinal Products for Human Use recommended approval for use in adjuvant treatment of adults with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy

Roche Holding AG, of Basel, Switzerland

Polivy (polatuzumab vedotin)

Anti-CD79b antibody-drug conjugate

Relapsed or refractory diffuse large B-cell lymphoma

EMA's Committee for Medicinal Products for Human Use recommended approval in combination with bendamustine plus Mabthera (rituximab) for adults who are not candidates for hematopoietic stem cell transplant

Shionogi & Co. Ltd., of Osaka, Japan

Fetroja (cefiderocol)

Antibacterial drug

Complicated urinary tract infections

FDA approved for use in patients 18 and older with complicated UTIs, including kidney infections caused by susceptible gram-negative microorganisms, who have limited to no alternative treatment options

Tricida Inc., of South San Francisco

Veverimer (TRC-101)

Non-absorbed orally administered polymer

Chronic kidney disease

FDA accepted the NDA under accelerated approval program; PDUFA date set for Aug. 22, 2020, and agency plans to hold a Cardiovascular and Renal Drugs Advisory Committee to discuss the application

Notes

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

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