The FDA rejects Gilead’s new drug application for filgotinib; new survey results on mental health care access for LGBTQ youth; Anthony S. Fauci, MD, thinks a mandatory coronavirus disease 2019 (COVID-19) vaccination is unlikely.
Late Tuesday, the FDA issued a complete response letter for Gilead Sciences’ new drug application for filgotinib, rejecting the new drug application, according to the company. More data from the MANTA and MANTA-Ray studies are needed on how the drug, which is being investigated as a potential treatment for rheumatoid arthritis, affects sperm count. The overall benefit/risk profile of 200-mg filgotinib dose is of particular concern to the FDA. Meanwhile, the drug has received a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use for marketing in the European Union, specifically for adults with moderate to severe RA.
The results of a survey conducted by The Trevor Project on over 40,000 teenagers and young adults ages 13 to 24 show that most LGBTQ youth who want access to mental health care services don’t get that chance, according to STAT News. Their top barriers are prohibitive costs, states that require parental permission for those younger than 18, and stigma related to disclosing their sexuality. The coronavirus disease 2019 (COVID-19) pandemic is creating additional barriers, said a Trevor Project official.
Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, does not think mandating the general public to get a COVID-19 vaccination will happen, says The Hill. However, one-third of Americans say they would not get such a vaccination even if it was available and free, with people of color and those who live in rural locations even less likely to do so. He also noted the possibility of employers refusing to let their employees return if they haven’t gotten the flu vaccine this year, especially those who work in health care, with USA Today reporting that overlap of the 2 viruses is imminent.