Your source for the latest industry trends and drug information news.
Volume 5 | Issue 8
May 15, 2023
Contributors:
Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate
On May 3, 2023, the U.S. Food & Drug Administration (FDA) announced the approval of the first vaccine for the prevention of respiratory syncytial virus (RSV) infection, Arexvy™. This vaccine is approved for people 60 and older, especially those with underlying health conditions. RSV is a highly contagious respiratory virus that commonly causes mild, cold-like symptoms. However, it can impact infants or older adults very seriously, causing life-threatening pneumonia and bronchiolitis. Each year, RSV leads to 6,000 to 10,000 deaths in adults over age 65. Health conditions like a weakened immune system and heart or lung disease put individuals at a much greater risk of contracting RSV and experiencing a severe infection, so it is recommended that they receive the vaccine when it becomes available.
The safety and efficacy of Arexvy™ is based on a randomized, placebo-controlled clinical study of people 60 and older. The study is ongoing, and participants will be monitored through three RSV seasons to help determine the duration of effectiveness and the safety of repeated vaccinations with Arexvy™. In this study, 12,500 participants received Arexvy™ and 12,500 participants received a placebo. A single dose of the vaccine from the first RSV season significantly reduced the risk of RSV-associated lower respiratory tract disease by 82.6% and severe RSV-associated lower respiratory tract disease by 94.1%. Atrial fibrillation was reported 30 days into the study in 10 participants receiving Arexvy™ and 4 participants receiving placebo.
Two additional studies of Arexvy™ were conducted, reviewing 2,500 participants who received the vaccine along with an FDA-approved influenza vaccine. Two participants developed a rare form of inflammation affecting the brain and spinal cord, acute disseminated encephalomyelitis (ADEM), and one of these participants died. Additionally, one participant developed Guillain-Barré syndrome 9 days after receiving Arexvy™. The FDA is requiring a post marketing study to assess risks for ADEM and Guillain-Barré syndrome, and GlaxoSmithKline will also review atrial fibrillation risk. Arexvy™ was granted Priority Review designation.
On May 2, 2023, the FDA announced that Akorn Operating Company LLC would remove several products from the market due to the company’s bankruptcy and the discontinuation of their Quality program. Previously, this Quality program ensured that drugs met the necessary purity, quality and identity requirements to stay on the market. The discontinuation of this program means that Akorn can no longer guarantee the integrity of these products, so they have chosen to recall various human and animal drugs within expiry. The human products can be found in this list provided by Akorn. This recall is not in response to a specific safety deficiency, and there have been no reports of adverse events related to it. Consumers are advised to contact their health care provider or veterinarian if they, or their pets, experience any adverse events. For human products, adverse reactions or quality issues should also be reported to the FDA MedWatch Adverse Event Reporting Program.
As part of their effort to address the opioid overdose crisis in the United States, the FDA has announced a new drug mail-back and disposal program for opioid analgesic products. This program requires manufacturers of opioids to provide prepaid mail-back envelopes that can be dispensed to patients receiving these prescription products in an outpatient setting. The goal of this program is to provide patients with safe and secure means to dispose of their unused medication. Many patients report having leftover opioid doses following surgical procedures for which these analgesics were prescribed for short-term pain management. Unfortunately, these unused medications can end up in the possession of friends or family members seeking them out. This mail-back program is intended to reduce nonmedical use, accidental exposure, development of opioid use disorder and overdose due to opioids. The FDA has issued a notice to manufacturers of this new requirement and anticipates implementation in 2024. Along with mail-back envelopes, manufacturers will be required to develop educational materials regarding the safe disposal of opioid medications. Once implemented, outpatient pharmacies will be able to order mail-back envelopes and educational materials from manufacturers to provide to patients with their dispensed opioids. The U.S. Postal Service has announced their commitment to this partnership with the FDA to prevent accidental exposure and overdose. This is one of many parts of the FDA Overdose Prevention Framework which aims to prevent opioid use disorder and overdoses.
Novel Drug Approval: Qalsody™ (tofersen sodium)
Spinal injection approved for the treatment of amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, in adult patients with an OSDI gene mutation. [04/25/2023 – BIOGEN INC]
New Dosage Form: Rizafilm® (rizatriptan benzoate)
Orally disintegrating film approved for the acute treatment of migraine in adult and pediatric patients 12 years and older and weighing at least 88 lbs. [04/14/2023 – INTELGENX CORP]
Iressa® (gefitinib)
Indication: Metastatic non-small cell lung cancer with specific alterations in the structure of the epidermal growth factor receptor (EGFR) protein.
Dosage Form/Strength: 250mg Oral Tablets
Average Wholesale Price (AWP): Generic = $8,272 | Brand = $9,347
