Novartis and Pfizer Lead Drug Approval News
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Novartis and Pfizer.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday March 8, 2017 to Tuesday March 14, 2017.
FDA OKs Novartis’ Breast Cancer Drug for Combo Therapy
The US Food and Drug Administration (FDA) has approved Novartis’ Kisqali (ribociclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for treating hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women.
Kisqali is a selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that was granted breakthrough therapy designation and priority review status by the FDA. The drug works by inhibiting the CDK 4/6 proteins, which play a role in cancer cell growth, according to Novartis. Kisqali was developed by the Novartis Institutes for BioMedical Research under a research collaboration with Astex Pharmaceuticals, a Cambridge, UK-headquartered biopharmaceutical company.
Pfizer Launches Antibiotic in UK, Germany
Pfizer has launched Zavicefta (ceftazidime-avibactam), a fixed-dose combination antibacterial that was developed to treat Gram-negative bacterial infections, in the UK and Germany, following an earlier marketing authorization approval in June 2016 by the European Medicines Agency.
Zavicefta is indicated for treating complicated intra-abdominal infection, complicated urinary tract infection, and hospital-acquired pneumonia, including ventilator associated pneumonia. Zavicefta is also indicated for treating infections due to aerobic Gram-negative organisms and addresses Pseudomonas aeruginosa and Enterobacteriaceae pathogens.
Pfizer expects to launch Zavicefta in additional markets outside the US throughout 2017 and 2018. Pfizer holds the global rights to commercialize Zavicefta, with the exception of North America (US and Canada), where the rights are held by Allergan.