Company Product Description Indication Status

Abbvie Inc., of North Chicago

Rinvoq (upadacitinib)

JAK inhibitor

Moderate to severe active rheumatoid arthritis

The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on the marketing application

Amgen Inc., of Thousand Oaks, Calif., and UCB SA, of Brussels, Belgium

Evenity (romosozumab)

Monoclonal antibody targeting sclerostin

Severe osteoporosis in postmenopausal women at high risk of fracture

Following a re-examination procedure, the EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on the marketing application

Amgen Inc., of Thousand Oaks, Calif.

Nplate (romiplostim)

Thrombopoietin receptor agonist

Immune thrombocytopenia

FDA approved the supplemental BLA to include newly diagnosed and persistent adult ITP patients who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy

Cipher Pharmaceuticals Inc., of Oakville, Ontario

Trulance (plecanatide)

Guanylate cyclase-C agonist

Irritable bowel syndrome with constipation

Health Canada approved the marketing application

Daiichi Sankyo Co. Ltd., of Tokyo

Quizartinib

Oral FLT3 inhibitor

Relapsed/refractory FLT3-ITD acute myeloid leukemia

EMA's Committee for Medicinal Products for Human Use adopted negative opinion for the MAA

Genmab A/S, of Copenhagen

Darzalex (daratumumab)

Monoclonal antibody targeting CD38

Multiple myeloma

The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on broadening the existing marketing application to include Darzalex plus lenalidomide and dexamethasone as treatment for newly diagnosed adult patients who are ineligible for autologous stem cell transplant

Isofol Medical AB, of Gothenburg, Sweden

Arfolitixorin

Active metabolite of folate-based drugs

Metastatic colorectal cancer

Japan's Pharmaceutical and Medical Devices Agency completed its review of the clinical trial notification, clearing the opening of Japanese sites in the ongoing, pivotal, phase III Agent study

Janssen Pharmaceutical Co., of Beerse, Belgium, a unit of Johnson & Johnson, of New Brunswick, N.J.

Spravato (esketamine)

Antagonist of the N-methyl-D-aspartate glutamate receptor

Treatment-resistant major depressive disorder

The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on the marketing application for the drug in combination with a selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor

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

Keytruda (pembrolizumab)

Monoclonal antibody targeting PD-1

First-line metastatic or unresectable recurrent head and neck squamous cell carcinoma

The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on expanding the marketing application to include Keytruda as a monotherapy or in combination with platinum therapy and 5-fluorouracil in patients whose tumors express PD-L1

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

Ervebo (V920)

Ebola Zaire vaccine

Ebola infection prophylaxis

The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending a conditional marketing authorization

Paratek Pharmaceuticals Inc., of Boston

Nuzyra (omadacycline)

Modernized tetracycline antibiotic

Acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia

Company withdrew its MAA from the EMA because the agency recommended approval for ABSSSI but not CABP; agency requested a second phase III study for CABP; withdrawing MAA for ABSSSI avoids starting clock for 10-year marketing exclusivity

Rigel Pharmaceuticals Inc., of South San Francisco

Fostamatinib

Spleen tyrosine kinase inhibitor

Chronic immune thrombocytopenia

The EMA's Committee for Medicinal Products for Human Use adopted a positive trend vote on the MAA; final vote expected at the November meeting

Vertex Pharmaceuticals Inc., of Boston

Kalydeco (ivacaftor)

Affects the gating of cystic fibrosis transmembrane conductance regulator

Cystic fibrosis

The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on expanding the marketing application to include infants ages 6 months to less than 12 months with specified mutations in the CFTR gene

Notes

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

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