Your source for the latest industry trends and drug information news.
Volume 4 | Issue 5
March 1, 2022
Contributors:
Chief Author: Dana Ranallo, PharmD
Contributing Author: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate
On February 11, 2022, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Eli Lilly and Company for its monoclonal antibody bebtelovimab for the treatment of mild to moderate COVID-19. Patients 12 years and older who weigh at least 88 pounds are eligible for treatment with bebtelovimab if they have a positive COVID-19 test and are at high risk for progression to severe COVID-19 (including hospitalization or death) and are not candidates for alternative FDA-approved COVID-19 treatments. Bebtelovimab is an intravenous medication that works by binding to a protein on the surface of the COVID-19 virus and preventing it from attaching to other cells in the body. The decision to grant the EUA was supported by data from a randomized, double-blind, phase 2 clinical trial which evaluated the efficacy of bebtelovimab alone and in combination with other monoclonal antibodies in non-hospitalized patients with mild to moderate COVID-19. Low-risk patients who were treated with bebtelovimab alone experienced a reduction in viral levels in the body at Day 5, and a faster time to sustained symptom resolution, when compared to placebo. High-risk individuals who were treated with bebtelovimab alone or in combination with other monoclonal antibodies had lower rates of hospitalization and death through Day 29 when compared to placebo. Overall, clinical data was similar between bebtelovimab use alone and in combination with other monoclonal antibodies. Laboratory testing has showed that bebtelovimab retains activity against the omicron variant and subvariants. The most common side effects of bebtelovimab include itching, rash, infusion-related reactions, nausea and vomiting. More serious side effects such as hypersensitivity, anaphylaxis and severe infusion-related reactions have been observed with administration of other monoclonal antibodies and could be possible with bebtelovimab. Bebtelovimab should not be used in patients who are hospitalized and/or require oxygen therapy or mechanical ventilation due to COVID-19. Vaccination against COVID-19 remains the best practice for reducing the risk of COVID-19 and related complications.
On February 3, 2022, the FDA released a Drug Safety Communication discussing the ongoing investigation of a possible increased risk of death with the cancer medication Ukoniq® (umbralisib). Ukoniq® is currently FDA approved for use in two different types of lymphomas (cancers affecting the body’s immune system): marginal zone lymphoma (MZL) and refractory follicular lymphoma (FL). Ukoniq® is in a class of medications called PI3 kinase inhibitors, which work by blocking the action of an abnormal protein which signals cancer cells to multiply. The recent safety investigation started after evaluation of safety data in a clinical trial, UNITY, which evaluated the use of Ukoniq® in combination with a monoclonal antibody for the treatment of another type of cancer, chronic lymphocytic leukemia (CLL). Results showed that patients treated with Ukoniq® had an increased risk of death and other serious adverse events when compared to the control group. Because of the similarity between the two types of cancers the drug is approved for the type of cancer studied in the most recent clinical trial, the FDA is reevaluating the risks against the benefits of Ukoniq® for its approved uses. Other PI3 kinase inhibitors have shown similar safety concerns when studied in clinical trials. The FDA recommends patients to reach out to their health care providers about their disease progresses, risks/benefits of Ukoniq® and potential alternative treatments. Adverse reactions related to the use of Ukoniq® should be made to the FDA’s MedWatch Adverse Event Reporting Program.
On December 20, 2021, the FDA approved Apretude® (cabotegravir extended-release injectable suspension) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Apretude® is approved for use in adults and adolescents weighing at least 77 pounds who are at risk for infection and have a negative HIV test before treatment initiation. Treatment is initiated with two injections administered one month apart, followed by one injection every two months thereafter. PrEP treatment requires a high level of adherence for patients to experience efficacy, so the approval of a long acting injectable is expected to help patients who have trouble with adherence to a once-daily medication. The approval was granted after favorable safety and efficacy data was reported in two different randomized, double-blind, clinical trials which compared Apretude® to Truvada®, a once daily oral medication. Trial 1 enrolled 4,566 HIV-uninfected men and transgender women who have sex with men, and it showed that participants who took Apretude® had a 69% lower risk of HIV infection when compared to those who took Truvada®. Trial 2, which enrolled 3,224 uninfected cisgender women, showed that participants who took Apretude® had a 90% lower risk of HIV infection when compared to those who took Truvada®. Cabotegravir was previously approved in January 2021 as the combination product Cabenuva® (cabotegravir and rilpivirine), a once-monthly injection for the treatment of HIV. On February 1, 2022, the FDA approved a label expansion for Cabenuva® to allow for administration every two months. This expansion further reduces the medication administration burden for patients undergoing HIV treatment and was granted after results from a global phase 3 clinical trial showed that once-monthly dosing was non-inferior to dosing every two months. The most common adverse reactions to Apretude® and Cabenuva® include injection site reactions, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.
Novel Drug Approval: Pyrukynd® (mitapivat)
Oral tablets approved for the treatment of hemolytic anemia, a rare inherited disorder resulting in destruction of red blood cells, in adult patients with pyruvate kinase (PK) deficiency. [02/17/2022 – Orphan Drug; Priority Review – AGIOS PHARMACEUTICALS INC]
New Dosage Form: Fleqsuvy™ (baclofen)
Oral suspension approved for the treatment of abnormal muscle tightness due to multiple sclerosis (MS). It may also be used in patients with spinal cord diseases such as spinal cord injuries. [02/04/2022 – AZURITY]
Selzentry® (maraviroc)
Indication: HIV
Dosage Form/Strength: 150 MG, 300 MG Tablets
Average Wholesale Price (AWP): Generic = $1,763.53 | Brand: $2,099.14
