GSK, J&J, and Pfizer Lead Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from GlaxoSmithKline, Johnson & Johnson, and Pfizer.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, February 7, 2017 to Tuesday, February 13, 2017.
J&J Submits MAA for Cancer Drug Apalutamide
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a marketing authorization application to the European Medicines Agency for apalutamide, an investigational oral androgen receptor (AR) inhibitor for treating patients with high-risk non-metastatic castration-resistant prostate cancer.
Apalutamide is an AR inhibitor that is expected to block the androgen signaling pathway in prostate cancer cells. Apalutamide is designed to inhibit the growth of cancer cells in three ways: (1) by preventing the binding of androgen to the AR; (2) by stopping the AR from entering the cancer cells; and (3) by preventing the AR from binding to the DNA of the cancer cell.
FDA Grants Breakthrough Therapy Designation for GSK’s Meningitis B Vaccine
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to GlaxoSmithKline’s (GSK) meningitis B vaccine, Bexsero [Meningococcal group B Vaccine (rDNA, component, adsorbed)], for preventing invasive meningococcal disease caused by serogroup B in children 2-10 years of age.
Breakthrough therapy designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate improvement over available therapy on a clinically significant endpoint(s).
Bexsero is licensed in more than 35 countries for preventing meningococcal disease. In the US, Bexsero is approved for use in individuals from 10 years through 25 years of age. The countries where Bexsero is licensed include the member states of the European Union (EU) and European Economic Area, which includes the EU member states and Iceland, Liechtenstein, and Norway. It is also approved in Australia, Argentina, Chile and Uruguay, where Bexsero is approved for individuals two months of age and older. It is appoved in Canada for those aged two months to 17 years of age. In Brazil, Bexsero is approved for use in individuals from two months to 50 years of age. To date, GSK says it has distributed more than 20 million doses of Bexsero worldwide.
FDA Accepts Pfizer’s NDA; Grants Priority Review for Lung Cancer Drug
The US Food and Drug Administration (FDA) accepted and granted priority review to Pfizer’s new drug application for lorlatinib, a drug for treating non-small cell lung cancer (NSCLC).
Lorlatinib is an investigational, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for treating patients with ALK-positive metastatic NSCLC, previously treated with one or more ALK TKIs. The European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency have also accepted marketing applications for lorlatinib.
The FDA grants priority review to medicines that may offer advances in treatment or may provide a treatment where no adequate therapy exists. In April 2017, lorlatinib received breakthrough-therapy designation from the FDA for patients with ALK-positive metastatic NSCLC previously treated with one or more ALK inhibitors.
The Prescription Drug User Fee Act goal date for a decision by the FDA is August 2018.