Your source for the latest industry trends and drug information news.
Volume 4 | Issue 1
January 1, 2022
Contributors:
Chief Author: Dana Ranallo, PharmD
Contributing Author: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate
On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Pfizer’s Paxlovid™ (nirmatrelvir and ritonavir), the first oral option available for the treatment of COVID-19. Paxlovid™, which is recommended to be taken within 5 days of symptom onset, is indicated for the treatment of mild-to-moderate COVID-19 disease in patients 12 years and older weighing at least 88 pounds who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid™ consists of a combination of medications that work to stop the COVID-19 virus from replicating. It is taken as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) twice daily for 5 days. The EUA was granted after the FDA analyzed results from a clinical trial which enrolled patients 18 years and older with a prespecified risk factor for progression to severe COVID-19 disease. Results showed that 0.8% of patients who received Paxlovid™ were hospitalized or died during a 28 day follow up, compared to 6% of patients who received placebo. Side effects of Paxlovid™ included impaired sense of taste, diarrhea, high blood pressure, and muscle aches. Paxlovid™ is not recommended for those with severe kidney or liver issues and is not approved for use as pre- or post-exposure prophylaxis or for treating those who are hospitalized due to severe or critical COVID-19. Patients should discuss whether they are a candidate for Paxlovid™ with their health care provider and be evaluated for potential drug interactions prior to treatment. On December 23, 2021, the FDA issued an EUA for a second oral treatment option, molnupiravir, which is intended for use in adults 18 and older with mild to moderate COVID-19 disease who are at high risk for progression to severe disease. Molnupiravir is taken as four 200mg capsules once daily for 5 days and is recommended for individuals for “whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate” as indicated by the FDA,. Clinical trial results showed the percentage of participants with all cause hospitalization or death through day 29 was found to be 7.3% in the molnupiravir group and 14.1% in the placebo group. Vaccination against COVID-19 remains the best practice for those who are eligible.
On December 7, 2021, the FDA announced Edge Pharma, LLC’s voluntary recall of all lots of all drugs compounded at Edge Pharma, LLC to the customer level due to possible process issues that could lead to a lack of sterility assurance for products intended to be sterile. Since flaws in the process could also lead to safety and quality issues for non-sterile products, both sterile and non-sterile products produced by Edge Pharma, LLC have been recalled. For products intended to be sterile, administration of compromised products may result in site specific infection, or even life-threatening serious systemic infections. The drugs impacted by this recall, which can be found on Edge Pharma’s website, include various local numbing agents used during medical procedures, oral numbing agents, and antibiotics, amongst others. Most of the drugs recalled were distributed between June and November of 2021. To date, Edge Pharma, LLC has not received any complaints of adverse events related to this recall. The company has notified its customers about the recall and provided information on all lots of recalled products. Patients should discontinue use immediately and discard or return the recalled lots. Patients experiencing any adverse events related to the recall are advised to contact their physician or health care provider and adverse reactions or quality problems relating to the recall should be reported to the FDA’s MedWatch Adverse Event Reporting Program.
On December 20, 2021, the FDA approved Apretude® (cabotegravir extended-release injectable suspension) for at-risk individuals weighing at least 77 pounds for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired human immunodeficiency virus (HIV). The efficacy of PrEP treatment relies on high levels of adherence, which may be difficult to achieve with current daily oral treatment options. Apretude® treatment is initiated via two injections, one month apart, followed by one injection every two months thereafter. Treatment may also be initiated using oral cabotegravir followed by one injection of Apretude® at months one and two, respectively, followed by one injection every two months thereafter. The approval was granted following positive results from two randomized, double-blind clinical trials that compared injectable Apretude® to Truvada®, an oral HIV PrEP treatment taken once daily. The first trial enrolled 4,556 cisgender men and transgender women who have sex with men, randomized to receive treatment with either Apretude® or Truvada®. Participants who received Apretude® had a 69% less chance of getting infected with HIV when compared to the Truvada® group. Trial 2 enrolled 3,224 cisgender women and found that those who took Apretude® had a 90% less chance of getting infected with HIV when compared to Truvada®. Side effects from Apretude® include injection site reactions, headache, fever, fatigue, back pain, rash, and muscle aches and pain. A negative HIV test should be obtained prior to each injection of Apretude® in order to reduce the risk of developing drug-resistant HIV variants. Individuals who have a history of less than desirable adherence to the daily oral PrEP regimens may stand to benefit from long-acting injectable medications such as Apretude®.
Novel Drug Approval: Leqvio® (inclisiran)
Injection approved for the treatment of adult patients with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD), both common diseases associated with high blood cholesterol levels, who require additional cholesterol lowering. [12/22/2021 – NOVARTIS PHARMS CORP]
New Dosage Form: Dartisla ODT (glycopyrrolate)
Oral disintegrating tablets approved for the treatment of adult patients with peptic ulcer. [12/16/2021 – EDENBRIDGE PHARMS]
Carbaglu® (carglumic acid)
Indication: Prevention and treatment of high blood ammonia levels
Dosage Form/Strength: 200MG Tablets
Average Wholesale Price (AWP): Generic = $6,553.08 | Brand = $7,940.52
