Emergent, Astellas & More Submit New Applications to FDA

Courtesy of Sarah Silbiger/Getty Images

With the submission of New Drug Applications and Biologics License Applications to the U.S. Food and Drug Administration, multiple companies are bidding for regulatory approval of drug candidates. BioSpace takes a look at several of the latest requests.

Embattled Emergent BioSolutions filed a BLA for its anthrax vaccine candidate, AV7909. The vaccine candidate is being assessed for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The FDA set a PDUFA date for April 2023.

Kelly Warfield, senior vice president of research and development at Emergent, said the development of the anthrax vaccine candidate was supported by the Biomedical Advanced Research and Development Authority and is supported by clinical evidence from multiple clinical studies.

“Over the last 20 years, Emergent has partnered with the U.S. government to lead this program from early- to advanced-stage development,” Warfield said in a statement. “As we progress toward licensure of AV7909, which is designed to follow a two-dose immunization schedule and to elicit a faster immune response, we redouble our efforts to support the government’s overall preparedness and response strategy for large-scale emergencies involving anthrax and other threats to public health.”

Japan-based Astellas Pharma has filed a New Drug Application for fezolinetant, an investigational selective neurokinin 3 (NK3) receptor antagonist developed for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Symptoms of menopause include hot flashes and night sweats.

It is estimated that 60% to 80% of women experience VMS during or after menopause. The NDA is supported by data from two pivotal Phase III studies, as well as a long-term Phase III study that is part of the SKYLIGHT program. However, another fezolinetant study in China missed the mark in an interim analysis of the Phase III MOONLIGHT 1 study.

Ahsan Arozullah, head of development therapeutic areas at Astellas, said the fezolinetant NDA is an essential step in bringing a new, first-in-class treatment option to women to “reduce the frequency and severity of moderate to severe VMS associated with menopause.”

In oncology, Italy’s Menarini Group and Radius Health submitted an NDA for the selective estrogen receptor degrader (SERD) elacestrant as a potential treatment for patients with ER+/HER2- advanced or metastatic breast cancer. The companies are seeking Priority Review, which would rapidly accelerate the potential approval time for the cancer drug.

The NDA is based on positive Phase III data from the EMERALD study that showed elacestrant provided positive progression-free survival results in the overall population and the estrogen receptor 1 (ESR1) mutation subgroup compared to standard of care treatment. The two companies said elacestrant is the first investigational oral SERD to show positive topline results in a pivotal trial for the treatment of ER+/HER2- advanced or metastatic breast cancer in postmenopausal women and men.

“We are excited about the potential for elacestrant to be approved for treatment of patients with advanced or metastatic ER+/HER2- breast cancer, which constitutes about 70% of breast cancer and remains an area of significant unmet medical need,” Elcin Barker Ergun, chief executive officer of Menarini said in a statement.

London’s Ellipses Pharma is beginning its journey toward an NDA with the acceptance of an Investigational New Drug application for EP0031, a next generation selective RET inhibitor that will be assessed as a treatment for RET-altered cancers. The company anticipates the first studies will focus on thyroid and non-small cell lung cancer.

Ellipses’ partner, Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. of China, has already begun a clinical trial assessing EP0031 in that country.