September 14 Pharmacy Week in Review: FDA Ensuring Compounding Quality, New Drug Therapy for Treating Asthma

This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings, and more. Our Week in Review is a can't miss for the busy pharmacy professional.

Nicole Grassano, Host: Hello and welcome to the Pharmacy Times News Network. I’m Nicole Grassano your host for our Pharmacy Week in Review.

The FDA is taking new steps to better ensure the quality of compounded drugs, while also preserving patient access to these medications, Pharmacy Times reported. In a statement, FDA Commissioner Scott Gottlieb said that the agency’s compounding program, which includes implementation and provisions of the law, is a priority.

In a revised draft memorandum of understanding, the FDA is making changes to its 2018 Compounding Policy Priorities Plan. The memorandum addresses investigations of complaints related to compounded drug products distributed outside the state, distribution of inordinate amounts of compounded drug products interstate, and submission and disclosure of information.

Patients with asthma with certain genotype combinations demonstrate more intense symptoms when combined with close proximity to roadways, suggesting that traffic-related air pollution exposure may affect the likelihood of asthma diagnosis and exacerbations, Contemporary Clinic reported. The study, the results of which were published in Scientific Reports, considered individual data on genotype, residential address, asthma diagnosis, and exacerbations from the Environmental Polymorphisms Registry.

Patients were divided into 3 groups—hyper-responders, hypo-responders, and neither—and they measured the participants' distance between their residence and nearest major road. Patients with certain genetic profiles had exhibited more intense symptoms following exposure to traffic pollution. Furthermore, patients with asthma who lacked this genetic profile did not have the same sensitivity to traffic pollution and do not experience worse asthma symptoms.

FDA officials recently granted breakthrough therapy designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype, Specialty Pharmacy Times reported. Tezepelumab is a potential first-in-class drug that blocks thymic stromal lymphopoietin or TSLP, an upstream modulator of multiple inflammatory pathways, according to Amgen.

Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control, Amgen and AstraZeneca said in a statement. The designation is based on data from the phase 2b PATHWAY trial, which showed a significant reduction in the annual asthma exacerbation rate compared with a placebo over a 52-week treatment period.

Pharmacists may get more questions about Ibrance if their patients have seen a new commercial for the prescription to treat breast cancer. In the spot, called “Carla,” it is an ordinary week for her, which makes it special. Even though Carla has metastatic breast cancer, she can still travel to a lakeside cabin with her family. She spends her time picking lavender, playing games, and enjoying her new normal. According to the commercial, Ibrance has been shown to be more effective at delaying her disease than letrozole.

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Thanks for watching our Pharmacy Week in Review. I’m Nicole Grassano at the Pharmacy Times News Network.