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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 4 | Issue 8
April 15, 2022

Chief Authors: Bonnie Broczkowski & Colleen Peehler
Contributing Author: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves Second Booster Dose for Older or Immunocompromised Patients

On March 29, 2022, the U.S. Food and Drug Administration (FDA) approved a second COVID-19 booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccine for older people and certain immunocompromised patients.  A second booster dose of the FDA-authorized Pfizer-BioNTech COVID-19 vaccine and the FDA-approved Comirnaty can be given to individuals age 50 and older as well as immunocompromised patients age 12 and older who received a first booster dose at least 4 months ago. A second booster dose of the FDA-authorized Moderna COVID-19 Vaccine and the FDA-approved Spikevax is approved for individuals age 50 and older and for those age 18 and older who are immunocompromised and received their first booster dose at least 4 months ago. A first booster dose had previously been approved by the FDA for patients 12 and older who completed their primary series at least 2 months prior for Jansen (J&J) vaccine or at least 5 months prior for Pfizer-BioNTech or Moderna vaccine. This approval of a second booster dose was granted after evaluating safety and efficacy data submitted by Pfizer-BioNTech and Moderna that showed no new safety concerns in participants who received a second booster dose at least 4 months after receiving the first booster dose. An ongoing, open-label, non-randomized clinical study demonstrated increased antibody levels against SARS-CoV-2 virus (including delta and omicron variants) in participants who received a second booster dose, compared to participants who received their first booster dose 5 months prior. Vaccination still remains the most effective way to prevent infection with COVID-19. The FDA recommends vaccination with an FDA-approved or FDA-authorized COVID-19 vaccine and staying up to date with booster doses if eligible.

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Drug Safety

Adamis Pharmaceuticals Corporation Recalls Symjepi® (Epinephrine) Injection

On March 22, 2022, the FDA announced Adamis Pharmaceuticals Corporation’s nationwide voluntary recall of certain lots of Symjepi® (epinephrine) pre-filled single-dose syringes. The recall was initiated due to potential clogging of the needle, which would prevent the dispensing of epinephrine in emergency situations. Epinephrine is used to treat allergic reactions including anaphylaxis, a rare but severe allergic reaction that can be life-threatening. Anaphylaxis symptoms appear quickly, causing skin rash, swollen throat, trouble breathing and chest tightness. This syringe malfunction could lead to life-threatening consequences if a patient is unable to inject the emergency medication during an allergic reaction. Although no adverse events related to this recall have been reported, there have been two different customer complaints of difficulty dispensing the product on three syringes. US WorldMeds (USWM), who exclusively markets and distributes Symjepi® in the United States, is notifying its customers about the recall. Consumers who have the recalled product should stop using it immediately. Adverse reactions or quality problems relating to the recall should be reported to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

FDA Approves Rinvoq® for the Treatment of Ulcerative Colitis

On March 16, 2022, the FDA granted approval to AbbVie’s Rinvoq® (upadacitinib) for the treatment of moderately to severely active ulcerative colitis in adult patients who did not respond to one or more biologic agents known as anti-tumor necrosis factor (anti-TNF) agents. Rinvoq® is an oral JAK inhibitor which works by blocking a specific pathway that causes inflammation. The medication was originally approved for the treatment of moderate to severe rheumatoid arthritis in 2019. It has also recently been approved for treatment of moderate to severe atopic dermatitis (approved January 2022), and active psoriatic arthritis (approved December 2021). Ulcerative colitis is a chronic inflammatory bowel disease (IBD) characterized by severe inflammation and ulcers in the gastrointestinal tract. While there is no cure for ulcerative colitis, patients can achieve periods of symptom-free remission with appropriate treatment. Current treatment options include corticosteroids, immune-modifying agents and anti-TNF agents. The approval of Rinvoq® for ulcerative colitis was granted after evaluating the safety and efficacy data in three randomized, double-blind, placebo-controlled clinical trials, two induction studies and one maintenance study[PC1] . The two induction studies showed that 26% and 33% of patients treated with Rinvoq® achieved remission compared to 5% and 4% in the placebo group. The maintenance study showed that 42% of patients treated with Rinvoq® 15 mg and 52% of patients treated with Rinvoq® 30 mg achieved remission compared to 12% in placebo. Rinvoq will provide a further treatment option for patients with moderately to severely active ulcerative colitis.

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FDA Approvals

New FDA Approvals

Novel Drug Approval: Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan)
This intravenous injection was approved for the treatment of a specific type of prostate cancer in adult patients with serum testosterone levels lower than 50 ng/dL who have been treated with first line hormonal therapy and chemotherapy. [03/23/2022 – Priority Review – AAA USA NOVARTIS]

New Dosage Form: Tlando™ (testosterone undecanoate)
Oral capsules approved as testosterone replacement therapy for adult male patients with testosterone deficiency. [03/28/2022 – ANTARES PHARMA INC] 

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New Generics

New Generics Entering the Marketplace

Zipsor® (diclofenac potassium)
Indication: Mild to moderate acute pain
Dosage Form/Strength: 25 MG Capsules
Average Wholesale Price (AWP): Generic = $502.79 | Brand = $558.72