One season winds down, another offers hints of a beginning.
I am afraid that both the regular Weekly Roundup as well as regular postings have lately been interrupted by some domestic issues that came up for me as well as a heavy travel schedule. Time to catch up – lots has happened though, and here are a few things I would bring to your attention while I get back on track:
- Mobile Medical App Approved for Many Types of Substance Abuse – This week FDA approved the first mobile medical app for use in treating substance abuse disorders. Called Reset, the app is intended for use with outpatient therapy to treat involvement with alcohol, cocaine, marijuana and stimulants, though not for use in opioid dependence. According to the FDA press release, the app contains a patient application and a clinical dashboard, supporting patients in skills intended to support abstinence and increase retention of outpatient therapy programs and will be available as a prescription-only adjunct treatment. The devise was reviewed by the agency through the de novo premarket review pathway which is for low-to-moderate-risk devices that are novel and for which there is no legally marketed predicate device which can claim substantial equivalence. Developed by a company that specializes in prescription digital therapeutics, which it refers to as “eFormulations”.
- Big Week in Oncology Medicines at FDA – Much to report here. Let’s first look to approvals. This week FDA announced approval of the first biosimilar to treat cancer. Amgen’s Mvasi (bevaczumab-awwb) (reference product is Avastin (bevaczumab)) was approved as a biosimilar, not as an interchangeable product, and is indicated for multiple types of cancer. The second piece of oncology news came from FDA in the form of an accelerated approval announcement regarding Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma, a slow growing form of non-Hodgkin lymphoma that frequently recurs. Aliqopa was granted priority review and has orphan drug status. While that covers two approvals out of the pipeline this week Sandoz announced this week that FDA also accepted a proposed BLA for a biosimilar for Rituxan® (rituximab) for the treatment of blood cancers as well as rheumatoid arthritis.
- FDA’s OPDP Issues Second Letter of the Year! – Unsure as to the date of posting to the FDA site, but a Warning Letter was sent August 24 by FDA’s Office of Prescription Drug Promotion. It is notable because it is only the second letter of the year, and the first Warning Letter. The letter went to the manufacturer of an opioid product and addressed the content of a “professional detail aid” that enumerated the benefits and uses of the pain control medication while failing to mention any of the risks associated with the product use. While Warning Letters generally contain multiple violations, given the concern regarding the opioid abuse epidemic, and the dangers noted in the label which included a boxed warning and limitations on use, this letter was sent in regard only to the lack of risk information and failure to fully state the limitations of use.
- FDA AdComm Recos Approval for Shingles Treatment – On September 13, the Vaccines and Related Biological Products Advisory Committee met to consider an application from GlaxoSmithKline for its shingles vaccine candidate Shingrix and unanimously recommended approval. According to media reports, the action date for a decision by FDA on the recommendation is October.
That’s it for me this week folks. Have a good weekend and more soon.