FDA Roundup: April 28, 2023

SILVER SPRING, Md., April 28, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

• Today, the FDA issued a final guidance for industry titled Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products, which replaces the draft guidance of the same name published in February 2019. The FDA intends for this guidance to assist sponsors in the clinical development of nicotine replacement therapy (NRT) drug products intended to help cigarette smokers stop smoking and for other related indications. See this CDER Statement for more information.
• Today, the FDA authorized the following uses of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 6 months through 4 years of age with certain types of immunocompromise who have previously received three 0.2 mL doses (Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent):
  • a fourth dose administered at least 1 month following the most recent dose;
  • additional doses that may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances.

The FDA also revised the Fact Sheets for Pfizer-BioNTech COVID-19 Vaccine, Bivalent, to reflect these changes.

• On Thursday, the FDA issued a Letter to Health Care Providers to inform health care providers and laboratory personnel about a cybersecurity vulnerability affecting the Universal Copy Service software in the Illumina MiSeqDx, NextSeq 550Dx, iScan, iSeq 100, MiniSeq, MiSeq, NextSeq 500, NextSeq 550, NextSeq 1000/2000, and NovaSeq 6000 sequencing instruments. These instruments may be specified either for clinical diagnostic use in sequencing a person’s DNA for various genetic conditions or for research use only (RUO). At this time, the FDA and Illumina have not received any reports indicating this vulnerability has been exploited.
• On Thursday, the FDA approved a modification to the Medtronic MiniMed 770G System to enable the firmware over-the-air (FOTA) update feature. The MiniMed 770G system is a hybrid closed loop system that is intended to automatically monitor glucose and adjust the delivery of insulin based on continuous glucose monitor values for people with type 1 diabetes mellitus. The FOTA feature will enable Medtronic to distribute firmware wirelessly to allow patients to receive firmware updates to their Bluetooth Low Energy (BLE)-enabled MiniMed 770G insulin pump without the need for the pump to be returned. The FOTA update will also allow current 770G pump users to upgrade their pump firmware to the recently approved MiniMed 780G firmware, which adds several new features to SmartGuard Technology. This is the latest example of the FDA’s ongoing commitment to ensure the development and expansion of products that can improve advanced treatment and successful management of type 1 diabetes.
• On Thursday, the FDA approved the vaccine, Prevnar 20, for the following indications and use:
  • for the prevention of invasive disease caused by the 20 different serotypes of Streptococcus pneumoniae contained in the vaccine for individuals 6 weeks through 17 years of age; and for the prevention of otitis media (ear infection) caused by 7 of the serotypes of Streptococcus pneumoniae contained in the vaccine for children 6 weeks through 5 years of age.
  • Prevnar 20 was initially approved by FDA in 2021 for the prevention of pneumonia and invasive disease caused by the 20 different Streptococcus pneumoniae serotypes contained in the vaccine for individuals 18 years of age and older.
  • Streptococcus pneumoniae is a bacterium that causes pneumonia and invasive pneumococcal disease, including meningitis (inflammation of the coverings of the brain and spinal cord) and bacteremia (bloodstream infections). Streptococcus pneumoniae is also a common cause of otitis media in children.
• On Wednesday the U.S. Marshals, at the FDA’s request, seized more than 250,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including over 1000 kilograms of bulk kratom. These dietary supplements are manufactured by Botanic Tonics LLC, located in Broken Arrow, Oklahoma. The dietary supplements (sold in liquid and capsule formulations) are marketed under the brands “Feel Free Plant Based Herbal Supplement.” The seized products are worth approximately $3 million. The U.S. Department of Justice, on behalf of the FDA, filed a complaint in the U.S. District Court for the Northern District of Oklahoma alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements and bulk dietary ingredients that are or contain kratom are adulterated under the Federal Food, Drug, and Cosmetic Act.

• On Tuesday, the FDA approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). Similar to sporadic ALS, where there are no associated risk factors and no family history of the disease, SOD1-ALS is a progressive neurodegenerative disease that attacks and kills the nerve cells that control voluntary muscles. Voluntary muscles produce movements such as chewing, walking, breathing, and talking. ALS causes the nerves to lose the ability to activate specific muscles, which causes the muscles to become weak and leads to paralysis.

  According to the Centers for Disease Control and Prevention, between 16,000 and 32,000 Americans are currently living with ALS. Approximately 2% of ALS cases are associated with mutations in the SOD1 gene; therefore, the agency estimates there are fewer than 500 patients with SOD1-ALS in the United States.

  The most common side effects were pain, fatigue, arthralgia (joint pain), increased cerebrospinal (brain and spinal cord) fluid white blood cells, and myalgia (muscle pain). See full prescribing information for additional information on risks associated with Qalsody.

• You can now follow FDA Chief Scientist Namandjé Bumpus on Twitter! Follow Dr. Bumpus at @DrBumpusFDA for important updates, and to learn more about the amazing science and research happening at FDA, and how FDA uses science to advance public health.
• COVID-19 testing updates:
  • As of today, 446 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 83 antibody and other immune response tests, 62 antigen tests, and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 29 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
  • The FDA has authorized 47 antigen tests and seven molecular tests for serial screening programs. The FDA has also authorized 1356 revisions to EUA authorizations.

Additional Resources:

• FDA Newsroom

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration