A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Merck & Co., AbbVie, Novartis, and Amgen.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, January 3, 2017 to Tuesday, January 9, 2017.

FDA Accepts NDA for Merck & Co.’s HIV Drug
The US Food and Drug Administration (FDA) has accepted Merck & Co.’s two new drug applications (NDAs) for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor, for treating HIV-1 infection in adults.

The NDAs include data for doravirine (DOR) as a once-daily tablet for use in combination with other antiretroviral agents, and for the use of doravirine with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) in a once-daily fixed-dose combination single tablet as a complete regimen (DOR/3TC/TDF). The FDA has set a target action date of October 23, 2018, for both applications under the Prescription Drug User Fee Act.

Source: Merck & Co.

FDA Grants AbbVie’s Dermatitis Drug Breakthrough Therapy Status
The US Food and Drug Administration (FDA) has granted AbbVie breakthrough therapy designation for upadacitinib an investigational, once-daily, oral Janus kinase inhibitor (JAK1 inhibitor) in adult patients with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

Atopic dermatitis, a chronic inflammatory skin disease, is characterized by skin erosion, oozing and crusting, redness, intense itching, and dry skin, according to information from the company 

Source: AbbVie

FDA Grants Novartis’ Breast Cancer Drug Kisqalir Breakthrough Therapy Status
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Novartis’ Kisqali (ribociclib) for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.

Kisqali is a selective cyclin-dependent kinase inhibitor developed to slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly, according to information from Novartis.

Kisqali was approved by the European Commission in August 2017 as an initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor. Kisqali is not currently approved for use in premenopausal women.

Kisqali is approved for use in 45 countries including the US and European Union. Kisqali was developed by the Novartis Institutes for BioMedical Research under a research collaboration with Astex Pharmaceuticals, a Cambridge, UK-based biotechnology company.

Source: Novartis    

Novartis Receives Breakthrough Therapy Status for Anemia Drug Promacta
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Novartis’ Promacta (eltrombopag) for use in combination with standard immunosuppressive therapy for treating patients with severe aplastic anemia (SAA) as a first-line therapy.

Promacta, which is marketed as Revolade in most countries outside the US, is approved as a second-line therapy in the refractory setting in SAA. Promacta is also approved for adults and children with chronic immune thrombocytopenia (ITP) who are refractory to other treatments.

Promacta/Revolade is approved in more than 100 countries worldwide for treating thrombocytopenia in adult patients with chronic ITP who have had an inadequate response or are intolerant to other treatments, in over 45 countries for treating patients with SAA who are refractory to other treatments, and in more than 50 countries for treating thrombocytopenia in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. The drug is approved in the US and in the European Union for treating thrombocytopenia in pediatric patients one year and older with chronic ITP who have had an insufficient response to corticosteroids and immunoglobulins.

Source: Novartis

Novartis Gets Priority Review for New Use of Cancer Drug in Combination Therapy
The US Food and Drug Administration (FDA) has granted priority review designation for Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with Stage III melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, following complete resection.

In October 2017, the FDA also granted breakthrough therapy designation to Tafinlar in combination with Mekinist for the adjuvant treatment of patients with Stage III melanoma with a BRAF V600 mutation following complete resection.

Tafinlar in combination with Mekinist is currently approved in the US for patients with unresectable or metastatic melanoma with a BRAF V600E/K mutation as detected by an FDA-approved test and non-small cell lung cancer with a BRAF V600E mutation.

Source: Novartis

EMA Accepts Amgen’s MAA for Osteoporosis Drug 
The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for Amgen’s and UCB’s Evenity (romosozumab), a drug for treating osteoporosis in postmenopausal women and in men at increased risk of fracture.

Evenity is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for treating osteoporosis. It is designed to work by inhibiting the activity of sclerostin, which enables Evenity to increase bone formation and reduce bone resorption simultaneously, according to information from Amgen.

Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop, and market antibody products targeting the protein, sclerostin. As part of this agreement, the two companies continue to collaborate on developing romosozumab for treating osteoporosis.

Source: Amgen