FDA OKs New Molecular Entities from Bayer, Merck & Co. and Daiichi

By Emily Forster -

August 15, 2019

A roundup of approvals of new molecular entities (NMEs) from the US Food and Drug Administration’s (FDA)’s Center for Drug Evaluation and Research (CDER), featuring NME approvals from Bayer, Merck & Co., Daiichi, Shield Therapeutics and Karyopharm Therapeutics.

Bayer Receives FDA Approval for Prostate-Cancer Drug Nubeqa

The FDA has approved Bayer’s Nubeqa (darolutamide), a non-steroidal androgen receptor inhibitor for treating non-metastatic castration-resistant prostate cancer.

The compound is developed jointly by Bayer and Orion, a Finnish pharmaceutical company.

Bayer has filed for approval of the compound in the European Union, Japan, and with other health authorities.

Source: Bayer

Merck & Co. Receives FDA Approval for Antibacterial Drug Recarbrio

The FDA has approved Merck & Co.’s Recarbrio (imipenem, cilastatin, and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections and complicated intra-abdominal infections.

Recarbrio is a three-drug combination injection containing imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor.

Source: Merck & Co., FDA

FDA Approves Daiichi’s Turalio for Rare Joint Tumor Therapy

The FDA has granted approval to Daiichi Sankyo’s Turalio (pexidartinibi) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.

TGCT is a rare tumor that affects the synovium (thin layer of tissue that covers the surfaces of the joint spaces) and tendon sheaths (layer of membrane that covers tendons, which are fibrous tissue that connect muscle to bone). The tumor is rarely malignant but causes the synovium and tendon sheaths to thicken and overgrow, causing damage to surrounding tissue, according to information from the FDA.

Daiichi says Turalio is the second of seven new products that the company is committed to delivering from its oncology pipeline by 2025.

Source: Daiichi Sankyo, FDA

FDA Approves Shield Therapeutics’ Accrufer for Iron Deficiency 

The FDA has approved Accrufer (ferric maltol) to Shield Therapeutics, a pharmaceutical company focused on addressing iron deficiency, as an iron-replacement product indicated for the treatment of iron deficiency in adults.

Ferracru, to be marketed as Accrufer in the US, is already approved in both the European Union and Switzerland.

Source: Shield Therapeutics

FDA Approves Karyopharm’s Xpovio for Relapsed Refractory Multiple Myeloma

The FDA has approved Xpovio (selinexor) tablets from Karyopharm Therapeutics, an oncology-focused pharmaceutical company, to treat adult patients with relapsed or refractory multiple myeloma.

Specifically, the drug was approved in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma, who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

A marketing authorization application for selinexor is currently under review by the European Medicines Agency.

Source: FDA, Karyopharm Therapeutics

FDA Approves TB Alliance’s Tuberculosis Drug Pretomanid

The FDA has approved pretomanid in combination with bedaquiline and linezolid from the Global Alliance for TB Drug Development (TB Alliance), for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs. Bedaquiline, pretomanid, and linezolid is a three-drug regimen collectively referred to as the BPaL regimen.

TB Alliance says pretomanid is the third new anti-TB drug approved for use by FDA in more than 40 years, as well as the first to be developed and registered by a not-for-profit organization.

TB Alliance says pretomanid is expected to be available in the United States by the end of 2019. The TB Alliance has submitted pretomanid as part of the BPaL regimen for review to the European Medicines Agency and to the World Health Organization for consideration of inclusion in treatment guidelines for highly drug-resistant TB.

Source: FDA, The Global Alliance for TB Drug Development