FDA Roundup: January 16, 2024

SILVER SPRING, Md., Jan. 16, 2024 /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 announced an open period for applications to support the development, implementation, and evaluation of a human abuse potential (HAP) study on the use of botanical kratom. Addressing the use of botanical Kratom is a priority as the FDA works to characterize its abuse potential and subjective effects, given the absence of published literature and clinical evaluations despite increased human use. According to the Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health, an estimated 1.9 million Americans aged 12 and older reported using kratom in 2022.

Today, the FDA approved Casgevy, a cell-based gene therapy, for the treatment of patients 12 years of age and older with transfusion-dependent beta-thalassemia, an inherited disorder characterized by life-long anemia requiring frequent blood transfusions. To produce Casgevy, patients’ hematopoietic (blood) stem cells are modified by genome editing utilizing novel CRISPR/Cas9 technology. The modified blood stem cells are transplanted back into the patient where they engraft (attach and multiply) within the bone marrow and increase the production of fetal hemoglobin (HbF), a type of hemoglobin that facilitates oxygen delivery and decreases the severity of anemia. The most common side effects were mouth sores, febrile neutropenia (fever associated with a low level of certain white blood cells), and decreased appetite. This application received Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations. Today’s approval signifies a second FDA-approved indication for Casgevy, as the product was also recently approved for the treatment of sickle cell disease in patients 12 years and older.

“Today’s approval is an important step in the advancement of an additional treatment option for individuals with beta-thalassemia, a debilitating disease that places individuals at risk of many serious health problems,” said Nicole Verdun, M.D., director of the Office of Therapeutic Products within the FDA’s Center for Biologics Evaluation and Research. “The approval of a cell-based gene therapy for this condition using CRISPR/Cas9 technology reflects FDA’s continued commitment to supporting safe and effective treatments that leverage the most promising and cutting-edge medical technologies.”

On Friday, the FDA authorized for marketing the DermaSensor Inc. DermaSensor device. It is a prescription device, indicated for the evaluation of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and over to assist health care providers in determining whether to refer a patient to a dermatologist. The device should be used in conjunction with the totality of clinically relevant information from the clinical assessment, including visual analysis of the lesion, by physicians who are not dermatologists. The device should be used on lesions already assessed as suspicious for skin cancer and not as a screening tool. The device should not be used as the sole diagnostic criterion nor to confirm a diagnosis of skin cancer. The FDA is requiring that the manufacturer conduct additional post-market clinical validation performance testing of the DermaSensor device in patients from demographic groups representative of the U.S. population, including populations who had limited representation of melanomas in the premarket studies, due to their having a relatively low incidence of the disease.

On Friday, the FDA approved pembrolizumab (Keytruda, Merck) with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer. The most common adverse reactions (≥10%) occurring in patients who received pembrolizumab with chemoradiotherapy were nausea, diarrhea, vomiting, urinary tract infection, fatigue, hypothyroidism, constipation, decreased appetite, weight loss, abdominal pain, pyrexia, hyperthyroidism, dysuria, rash, and pelvic pain. View the full prescribing information for Keytruda.

On Friday, the FDA issued a safety alert advising restaurants and retailers not to serve or sell and consumers not to eat certain oysters from Bahia Salina in Sonora, Mexico potentially contaminated with Norovirus.

On Friday, the FDA authorized for marketing Fibresolve, a software-only device that receives and analyzes lung computed tomography images to aid in the referral of patients with suspected findings related to scarring of the lungs due to idiopathic pulmonary fibrosis. The device is intended to supplement the current standard-of‐care workflow by providing a qualitative, diagnostic classification output of imaging findings based on machine learning pattern recognition. Fibresolve provides adjunctive information that can be used during an expert Multidisciplinary Discussion with a patient’s clinical history, symptoms, and other diagnostic tests to help lung disease health care specialists make an appropriate diagnosis. The FDA granted marketing authorization of Fibresolve to Imvaria, Inc.

 Additional Resources: 

FDA Newsroom 

Media Contact: FDA Office of Media Affairs, 301-796-4540 
Consumer Inquiries: 888-INFO-FDA 

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, radiation-emitting electronic products, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration