Your source for the latest industry trends and drug information news.
Volume 4 | Issue 4
February 15, 2022
Contributors:
Chief Author: Dana Ranallo, PharmD
Contributing Author: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate
On January 27, 2022, Moderna published an update regarding a phase 1 clinical trial studying its mRNA HIV vaccine developed in collaboration with IAVI. The company announced that the first participants have been vaccinated with the initial doses of HIV vaccines. The trial aims to test both efficacy and safety of a primary dose and a booster dose of the mRNA HIV vaccine. Messenger RNA (mRNA) vaccines work by causing our cells to produce a protein called an antigen which triggers the desired immune responses in the body. mRNA technology is a novel technology and is currently being used in two highly effective COVID-19 vaccines made by Moderna and Pfizer. The safety of the HIV vaccine is being tested in 56 healthy volunteers who will receive various combinations of a primary dose, booster or both vaccines. The vaccines being administered in the clinical trial are designed to carry an HIV-specific antigen to the body with the goal of triggering an immune response against HIV viruses. A previous trial showed that the HIV antigens used in these vaccines produced an immune response in 97% of the participants. In addition to HIV, mRNA technology has prompted researchers to study the use of mRNA vaccines in immunotherapy to treat cancers, autoimmune disorders, genetic disease and chronic infectious diseases such as hepatitis B and herpes.
On January 19, 2022, the U.S. Food and Drug Administration (FDA) announced Mylan Pharmaceuticals Inc.’s voluntary recall of one batch of Semglee® (insulin glargine injection) 100 units/ml (U-100) prefilled pens due to the potential of missing labels on some pens. Semglee®, which is packaged in cartons of five 3 ml pens, is a long-acting human insulin analog indicated for the treatment of type 1 and type 2 diabetes mellitus (DM) in adult and pediatric patients. Although the cartons are expected to be correctly labeled, a missing pen label may result in administration of a higher or lower than intended amount of insulin which could lead to high or low blood sugar or incorrect product usage for individuals taking multiple types of insulin. Mylan had not received any complaints or reports of any adverse events at the time of the recall. The company has provided information for returns and requested distributors to check inventory and discontinue distributing the recalled batch. Patients should check their Semglee® prefilled pens and return any recalled or unlabeled products. Adverse reactions or quality problems related to the recall should be made to the FDA’s MedWatch Adverse Event Reporting Program.
On January 21, 2022 the FDA approved AbbVie’s Skyrizi® (risankizumab-rzaa) for the treatment of adult patients with psoriatic arthritis. Psoriatic arthritis (PsA), a systemic inflammatory disease, is a complication of psoriasis that is characterized by joint pain, stiffness and swelling that impacts an estimated 30% of individuals with psoriasis. While no cure for PsA exists, there are treatments available aimed at improving patients’ quality of life by controlling symptoms and preventing further joint damage. The safety and efficacy of Skyrizi® in the treatment of PsA was evaluated in two clinical trials, KEEPsAKE-1 and KEEPsAKE-2. Both trials enrolled adult patients with active PsA and included those who had inadequate responses or intolerance to biologic therapies and/or non-biologic disease-modifying antirheumatic drugs (DMARDs). Skyrizi® was dosed as a single 150 mg injection under the skin at weeks 0, 4, and 16, with results measured at 24 weeks. The primary endpoint of the studies was measurement of ACR20 response (an improvement of 20% in the number of tender and swollen joints). Over 50% of patients who received Skyrizi® achieved the primary endpoint of ACR20 response at week 24 in both trials, versus 33.5% and 26.5% of patients who received placebo in KEEPsAKE-1 and KEEPsAKE-2 respectively. This approval of Skyrizi® will provide dermatologists and rheumatologists with an additional treatment option to help improve skin and joint symptoms in patients with PsA.
Novel Drug Approval: Kimmtrak® (tebentafusp-tebn)
Injection approved for the treatment of uveal melanoma, a type of rare eye cancer, in adult patients. [01/25/2022 – Orphan Drug – IMMUNOCORE LTD]
New Dosage Form: citalopram hydrobromide
Oral capsules approved for the treatment of Major Depressive Disorder (MDD) in adult patients. [01/31/2022 – ALMATICA]
*As of this issue, there were no new generics entering the marketplace. However, there are several projected launches we are monitoring, including:
Vimpat® (lacosamide)
Indication: Seizures
Dosage Form/Strength: Injection, solution and tablets
Projected Launch: Generic = March 17, 2022
