COVID-19 Drug Gets Expanded EUA Authorization
According to Eli Lilly and Company and Incyte, the FDA has broadened Emergency Use Authorization (EUA) for baricitinib in treating hospitalized COVID-19 patients age two and older who require supplemental oxygen, noninvasive or invasive ventilation, or ECMO. Baricitnib is a once-daily, oral JAK inhibitor for use with or without remdesivir. Previously baricitnib was only approved for use with remdesivir. The decision to expand the use of baricitinib was based on a phase 3 study showing some advantage in progression to noninvasive ventilation or invasive ventilation and death among patients who received the drug. Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines, says the approval “provides physicians additional treatment regimen options for baricitinib to continue to meet the urgent medical needs posed by this pandemic.” Read More
FDA Issues HBOT Consumer Alert
The FDA issued a MedWatch alert regarding the use of hyperbaric oxygen therapy (HBOT), specifically warning consumers to be sure that they check with their health care providers before seeking out this therapy. The FDA notes that while HBOT has been approved for conditions such as carbon monoxide poisoning, skin and bone infections, and radiation injury, among others, it has not been approved to treat conditions like cancer, Lyme disease, autism, or Alzheimer’s disease. The government agency also wants people to make sure that if they do seek HBOT, they seek it from a hospital or facility that has been inspected and accredited by the Undersea and Hyperbaric Medical Society. Read More
Generic Equivalent of Spriva Handihaler On the Way
Lannett Company, Inc., has entered into a 10-year agreement with Respirent Pharmaceuticals Co. Ltd. for the exclusive U.S. commercialization of tiotropium bromide inhalation powder, the generic equivalent of the Spriva Handihaler made by Boehringer Ingelheim. The deal comes after a similar agreement the companies made to market generic versions of the ADVAIR DISKUS and Flovent Diskus made by GlaxoSmithKline. “We continue to add drug and device combination respiratory medications to our pipeline,” said Lannett CEO Tim Crew. The company is committed to providing affordable respiratory medicines for asthma and COPD. Read More
FDA Approves IV Version of PAH Treatment
The FDA approved an intravenous form of UPTRAVI for people with pulmonary arterial hypertension (PAH) who are temporarily unable to continue with the tablet form of the therapy. UPTRAVI IV is indicated for adults with WHO function class II-III PAH. The FDA approved the treatment’s tablet form in 2015 to delay disease progression and reduce the risk of hospitalization in these patients. “For patients on UPTRAVI, bridging short-term temporary interruptions of UPTRAVI tablets with UPTRAVI IV may maintain the treatment effect and avoid the need to change therapy or re-titrate UPTRAVI tablets after re-initiation,” said Kelly Chin, MD, UPTRAVI® IV study senior author from the University of Texas Southwestern Medical Center. The therapy is made by the Janssen Pharmaceutical Companies of Johnson & Johnson. Read More
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Debbie Bunch is an AARC contributor who writes feature articles, news stories, and other content for Newsroom, the AARC website, and associated emailed newsletters. In her spare time, she enjoys reading, traveling, photography, and spending time with her children and grandchildren. Connect with Debbie by email or on AARConnect or LinkedIn.
