Pfizer, Astellas Lead Drug Approval NewsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Pfizer, and Astellas Pharma.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday July 11 to Tuesday July 17, 2018.
FDA OKs New Use for Pfizer’s, Astellas’ Drug Xtandi in Prostate Cancer
The US Food and Drug Administration (FDA) has approved a new indication for Astellas Pharma’s and Pfizer’s Xtandi (enzalutamide), a drug for treating prostate cancer, to include men with non-metastatic castration-resistant prostate cancer (CRPC).
Xtandi was first approved by the FDA in 2012 for treating patients with metastatic CRPC who had previously received docetaxel. The drug was approved by the FDA in 2014 for treating chemotherapy-naïve men with metastatic CRPC.
Pfizer gained Xtandi through its $14-billion acquisition of Medivation, a San Francisco-based biopharmaceutical company, in 2016. Medivation was partnered with Astellas for the development and commercialization of Xtandi.
Source: Pfizer and Astellas Pharma
FDA Approves Smallpox Drug
The US Food and Drug Administration (FDA) has approved Tpoxx (tecovirimat) for treating smallpox from Siga Technologies, a New York-based pharmaceutical company. The drug, a small-molecule antiviral treatment, is the first drug indicated for treating smallpox, according to the FDA.
“To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons,” said FDA Commissioner Scott Gottlieb in a July 13, 2018 agency statement. “Today’s approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon.”
Concurrent with the approval, the FDA granted Siga’s request for a Priority Review Voucher (PRV). A PRV is a voucher that may be used to obtain an accelerated FDA review of a future SIGA product, or sold to a third party, and this is the first PRV awarded under the Material Threat Countermeasure PRV program enacted by the 21st Century Cures Act, according to information from Siga.
In addition, the FDA approved a seven-year expiry for Tpoxx. Under Siga’s existing contract with the Biomedical Advanced Research and Development Authority (BARDA) under the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, the company will ask BARDA to exercise an option for a $50-million payment to the company based on this extended shelf-life determination. The exercise of this option is at the sole discretion of BARDA. With the approval, Siga is entitled to a $41-million hold-back payment under the existing contract with BARDA, provided that BARDA confirms that there is no difference between the approved product and the courses of Tpoxx that have already been delivered to the US government’s Strategic National Stockpile (SNS).
Tpoxx will be available initially only through the US government’s SNS. Siga has a $472-million procurement and development contract with BARDA as part of which 2 million courses of oral Tpoxx have been delivered to the SNS. Currently, there is a Request for Proposal outstanding for the maintenance of a smallpox antiviral stockpile within the SNS. Siga says it intends to explore additional markets and potential indications for Tpoxx in the US and around the world.
Source: FDA, Siga Technologies