The U.S. Food and Drug Administration has granted marketing authorization to the Cue COVID-19 Molecular Test, which is a nucleic acid amplification test designed to detect genetic material from the SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of upper respiratory infection. This is the first-ever at-home test authorized by the FDA using a traditional premarket review pathway for any respiratory illness, and it is also the first at-home COVID-19 test granted marketing authorization outside of emergency use authorities.

The Cue COVID-19 Molecular Test is a molecular nucleic acid amplification test, consisting of a single-use Cue COVID-19 test cartridge, a single-use Cue sample wand, and the Cue cartridge reader. It uses the Cue Health app to display results when the test is complete, and the reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the app in about 20 minutes. In a study reviewed by the FDA, the test correctly identified 98.7% of negative and 92.9% of positive samples in individuals with signs and symptoms of upper respiratory infection.

There is a risk of false positive and false negative results, and individuals who test positive should avoid spreading the virus and should seek follow-up care with their physician or healthcare provider as additional testing may be necessary. Negative results should be confirmed by a lab-based molecular test if necessary for patient management.

The FDA has established criteria called special controls that define the requirements related to labeling and performance testing, and they have created a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway. The FDA has granted the marketing authorization to Cue Health Inc.

For more information, please read the press release: https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-covid-19-home-test-using-traditional-premarket-review-process

More news on the topic: https://www.labpulse.com/business-insights/policy-and-regulation/regulatory-approval/article/15540028/cue-health-granted-first-traditional-fda-authorization-for-athome-test-to-detect-respiratory-illness

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Source FDA

https://stmdailynews.com/category/lifestyle/health-and-wellness/fda-cdc-news/

The United States Food and Drug Administration (FDA) has announced additional steps to modernize clinical trials in an effort to increase efficiency and improve patient outcomes. The agency has released draft recommendations and is seeking feedback on how they should be applied to increasingly diverse trial types and data sources.

The new guidelines aim to address challenges in clinical trial design and execution, including the use of real-world evidence (RWE) and increasing diversity in clinical trial populations. The FDA recognizes the importance of incorporating RWE in clinical trials to provide a more comprehensive understanding of a drug’s safety and efficacy in real-world settings. The agency is also committed to increasing diversity in clinical trials to ensure that all patient populations receive equal access to potentially life-saving treatments.

The draft recommendations suggest new approaches to trial design, such as the use of adaptive designs and master protocols, to increase efficiency and reduce costs. Adaptive designs allow for changes to be made during the trial based on emerging data, while master protocols enable multiple drugs to be tested simultaneously in a single trial. The FDA also recommends the use of innovative trial designs, such as basket and umbrella trials, which allow for the testing of multiple drugs in a single trial on patients with similar genetic profiles or disease types.

The FDA is also exploring the use of decentralized clinical trials, which rely on technology to enable patients to participate in trials from their homes. This approach has the potential to increase participation in clinical trials and reduce the burden on patients who may have difficulty traveling to study sites. The FDA acknowledges that the use of technology in clinical trials has the potential to improve efficiency and reduce costs while maintaining the integrity of the data.

Finally, the FDA is committed to increasing diversity in clinical trials by encouraging the inclusion of underrepresented populations, such as women, racial and ethnic minorities, and the elderly. The agency is exploring ways to incentivize the inclusion of these populations in clinical trials and is partnering with patient advocacy groups to increase awareness and understanding of the importance of clinical trial diversity.

In conclusion, the FDA’s draft recommendations for modernizing clinical trials represent a significant step forward in improving patient outcomes and increasing efficiency in drug development. By incorporating RWE, innovative trial designs, and technology, while also increasing diversity in clinical trial populations, the agency is working to ensure that all patients have equal access to potentially life-saving treatments. The FDA is requesting feedback on these draft recommendations, and it is hoped that the final guidelines will reflect the input of a diverse range of stakeholders.

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https://www.fda.gov/news-events/press-announcements/fda-announces-additional-steps-modernize-clinical-trials?utm_medium=email&utm_source=govdelivery

https://stmdailynews.com/category/lifestyle/health-and-wellness/health/

SILVER SPRING, Md. /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in the FDA’s Center for Drug Evaluation and Research. “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”

Menopause is a normal, natural change in a woman’s life when her period stops, usually occurring between ages 45 and 55. Menopause is often referred to as “the change of life” or “the change.” During menopause a woman’s body slowly produces less of the hormones estrogen and progesterone. A woman has reached menopause when she has not had a menstrual period for 12 consecutive months. Hot flashes occur in around 80% of menopausal women and can include periods of sweating, flushing and chills lasting for several minutes.

Some women who experience hot flashes and have a history of vaginal bleeding, stroke, heart attack, blood clots or liver disease, cannot take hormone therapies. Veozah is not a hormone. It targets the neural activity which causes hot flashes during menopause.

Patients taking Veozah should take one 45 milligram pill orally, once a day, with or without food. The pill should be taken at the same time each day. If a dose is missed, or not taken at the regular time, patients should take it as soon as possible and return to their regular schedule the following day.

The effectiveness of Veozah to treat moderate to severe hot flashes was demonstrated in each of the first 12-week, randomized, placebo-controlled, double-blind portions of two phase 3 clinical trials. In both trials, after the first 12 weeks, the women on placebo were then re-randomized to Veozah for a 40-week extension study to evaluate safety. Each trial ran a total of 52 weeks. The average age of the trial participants was 54 years old.

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The prescribing information for Veozah includes a warning for elevated hepatic transaminase, or liver injury. Before using Veozah, patients should have blood work done to test for liver damage or infection. While on Veozah, routine bloodwork should be performed every three months for the first nine months of using the medication. Patients experiencing symptoms related to liver damage—such as nausea, vomiting, or yellowing of the skin and eyes—should contact a physician. Veozah cannot be used with CYP1A2 inhibitors. Patients with known cirrhosis, severe renal damage or end-stage renal disease should not take Veozah.

The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated hepatic transaminases.

The FDA granted the Veozah application Priority Review designation.

The approval of Veozah was granted to Astellas Pharma US, Inc.

Additional Resources:

• Menopause
• Menopause & Hormones Common Questions
• Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine-Division of Urology, Obstetrics, and Gynecology (DUOG)

SOURCE U.S. Food and Drug Administration

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