5 Approvals and Updates From the FDA This Week

This past week was filled with updates from the FDA, from new guidance on digital health oversight to multiple new drug approvals for cancer gene profiling, opioid use disorder, type 2 diabetes, and breast and stomach cancers.

New Digital Health Policies

The FDA released a statement on 3 new guidance documents to advance the administration’s approach to new digital health policies. The first draft guidance, “Clinical and Patient Support Software,” outlines the FDA’s approach to clinical decision support software (CDS), and makes clear what type of CDS would no longer be defined as a medical device, and thus would not be regulated by the agency.

“Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Act” addresses other digital health provisions included in the Cures Act. The guidance outlines the FDA’s interpretation of the types of software that are no longer considered medical devices, such as mobile apps intended only for maintaining or encouraging a healthy lifestyle.

The final guidance, “Software as a Medical Device: Clinical Evaluation,” establishes common principles for regulators to use in evaluating the safety, efficacy, and performance of Software as a Medical Device (SaMD). It provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product, according to the FDA.

Cancer Gene Profiling Test

The first-of-a-kind comprehensive companion diagnostic test for solid tumors has gained FDA approval. Foundation Medicine’s FoundationOne CDx examines all classes of genomic alterations in the hundreds of genes known to cause cancer growth, providing a more complete picture of what’s driving tumor growth and guidance on treatment decisions. Previous comprehensive genomic profiling testing showed that 1 in 3 patients across 5 common advanced cancers will likely match with an FDA-approved therapy.

Long-Acting Drug for Opioid Use Disorder

People with moderate-to-severe opioid use disorder will soon have access to a long-acting version of buprenorphine following the FDA’s approval of an injectable form of the drug. The FDA recommended that the drug, marked under the name Sublocade, should be used as part of a complete treatment package that includes counseling and psychosocial support. The drug will cost $1580 per monthly dose.

Once-Weekly GLP-1 for Type 2 Diabetes

This week Novo Nordisk announced the FDA's approval of its once-weekly glucagon-like peptide-1 (GLP-1) receptor, semaglutide. Already having proof of cardiovascular benefits, the drug received approval for 2 doses, 0.5 mg and 1.0 mg, that will be administered through a pre-filled pen. The approval comes after semaglutide beat out its rival in a head-to-head trial.

As part of its post-approval requirements, Novo Nordisk will conduct a pediatric trial in adolescents under age 18 and add semaglutide to the 15-year medullary thyroid carcinoma registry being kept for all long-acting GLP-1 therapies.

First Biosimilar for Treating Breast and Stomach Cancers

The list of approved biosimilars in the US is growing, with the first biosimilar for the treatment of breast and stomach cancers receiving FDA approval. Mylan GmbH’s trastuzumab-dkst has been approved as a biosimilar to trastuzumab for patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene. The approval comes after a review of evidence that included animal study data, clinical immunogenicity data, and human pharmacokinetic and pharmacodynamics data.