1Q 2022 FDA Drug Approvals
Prodigy provides Program Alerts on regulatory development, rule changes and FDA drug pipeline for new (novel) drug as well as generic drug approvals. In Q1 2022, the FDA approved several novel drugs and new generics which will undoubtedly have serious financial impact in payers drug mix and drug spend. For example, a 2-5% change reduction in brand utilization could yield between 7-20% reduction in drug spend. Below is a review of some of the novel and generic drugs approved by the FDA in 1Q 2022. Please note that Prodigy provides specific Program Alerts that are tailored to our workers’ compensation clients. For more details on the workers’ compensation FDA Pipeline Alert, contact pharmd@prodigyrx.com.
Novel Drug Approvals
Quviviq is a novel drug used to treat insomnia. Approval was based on two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies implemented a 7-day placebo runout period after subjects were treated with Quviviq for three months [1]. According to GlobeNewswire the total operating expenses for Quviviq was approximately $1.26 billion for 2021[2]. A month supply of Quviviq is $430 making the yearly cost of treatment $5,160[3].
Cibinqo is a Janus kinase 1 inhibitor used to treat refractory moderate to severe atopic dermatitis. Five clinical trials with over 1,600 evaluated the safety and efficacy of Cibniqo [2]. According to Lexicomp one tablet costs $196.56 making a month supply of Cibinqo $5,896.80 [5].
Kimmtrak is a novel drug with FDA approval to treat unresectable or metastatic uveal melanoma. A randomized controlled trial with 378 patients used overall survival as a primary end point when evaluating the safety and efficacy of Kimmtrak [6]. On average, treatment for each patient is about 5 months which costs approximately $400,000 [7].
For more details on the workers’ compensation FDA Pipeline Alert, contact pharmd@prodigyrx.com.
For more details on the workers’ compensation FDA Pipeline Alert, contact pharmd@prodigyrx.com.
Vabysmo is a novel drug used to treat neovascular macular degeneration and diabetic macular edema. A phase 3 clinical trial revealed that after 4-month patients treated with Vabysmo achieved vision gains compared to those who were given aflibercept. Vabysmo was well tolerated in most patients and the most reported adverse effect was conjunctival hemorrhage [9]. Genentech has set the current cost per treatment to $2,190[10].
Vonjo was recently approved for treatment in patients with intermediate to high risk for myelofibrosis. The results collected from PERSIST-2, a phase 3 clinical trial, allowed the FDA to give Vonjo accelerated approval. The study utilized randomization to assign patients treatment of Vonjo 200mg, Vonjo 400 mg, or the best available therapy on the market. When assessing the primary end point, a reduction in spleen volume, Vonjo proved to be more effective. This is supported by the fact that Vonjo reduced spleen volume 33% more than the best available therapy. The most common side effects reported include diarrhea, anemia, peripheral edema, nausea, and thrombocytopenia [11]. The current monthly wholesale acquisition cost of Vonjo is $19,500 [12].
Enjaymo was recently approved to decrease the need for red blood cell transfusion due to hemolysis in those with cold agglutinin disease. In a six-month study where 24 participants were treated with Enjamyo 54% responded to treatment. The 54% who responded experienced an increase in red blood cells and participants did not receive a blood transfusion or any other form of treatments after the first five weeks of the study [13]. The wholesale acquisition cost of Enjaymo is $1,800 a vial [14].
Pyrukynd is a novel drug used to treat patients with hemolytic anemia. Before Pyrukynd the only forms of treatment for this condition were red blood cell transfusions or a splenectomy [15]. A randomized double-blind study monitored the hemoglobin levels in 80 individuals who were given Pyrukynd 50 mg up to two times daily [16]. Effectiveness was determined based on hemoglobin levels which represented the red blood cells that were not destroyed. After 24 weeks 40% of participants had a hemoglobin response which confirmed the drug’s effectiveness. The most common side effects include back pain, joint stiffness, and decreased levels of estrone and estradiol in men [16]. The annual wholesale price of Pyrukynd is about $334,880 [17].
First-Time Generics
Contributor:
Sarah P Cirildo, Pharm D Candidate
References
[1] Dorsia receives US FDA approval of QUVIVIQ (daridorexant) 25 and 50 mg for the treatment of adults with insomnia. Idorsia receives US FDA approval of QUVIVIQ (daridorexant) 25 and 50 mg for the treatment of adults with insomnia. (n.d.). Retrieved March 3, 2022, from https://www.idorsia.com/media/news-details?newsId=2665386
[2] Idorsia Pharmaceuticals Ltd. (2022, February 8). Idorsia announces financial results for 2021 – 2022 to be a transformative year – sustainable profitability expected in 2025. GlobeNewswire News Room. Retrieved March 21, 2022, from https://www.globenewswire.com/en/news-release/2022/02/08/2380470/0/en/Idorsia-announces-financial-results-for-2021-2022-to-be-a-transformative-year-Sustainable-profitability-expected-in-2025.html
[3] Tanya von Reuss BioPharma Media’s Scientific Editor. Tanya has been dedicated to forensic science and molecular pathology for two decades. Her professional interests include thanatology, & Reuss, T. von. (2022, February 14). Quviviq: New sleeping pill. BioPharma Media. Retrieved March 21, 2022, from https://biopharma.media/quviviq-new-sleeping-pill-3201/
[4] U.S. FDA approves Pfizer's CIBINQO® (abrocitinib) for adults with moderate-to-severe atopic dermatitis. Pfizer. (n.d.). Retrieved March 3, 2022, from https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-cibinqor-abrocitinib-adults
[5] Home Page: Cibinqo (abrocitinib): Safety Info. CIBINQO. (n.d.). Retrieved March 21, 2022, from https://www.cibinqo.com/
[6] Dunleavy, K. (2022, January 26). Immunocore wins FDA nod for first uveal melanoma treatment, also first T-cell receptor therapeutic. Fierce Pharma. Retrieved March 5, 2022, from https://www.fiercepharma.com/pharma/immunocore-wins-fda-nod-for-kimmtrak-first-treatment-for-uveal-melanoma-and-first-t-cell
[7] Center for Drug Evaluation and Research. (n.d.). FDA approves tebentafusp-tebn for unresectable. U.S. Food and Drug Administration. Retrieved March 10, 2022, from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma
[8] Metastatic uveal melanoma treatment. KIMMTRAK. (n.d.). Retrieved March 09, 2022, from https://www.kimmtrakconnect.com/
[9] Genentech: Press releases: Friday, Jan 28, 2022. Genentech: Press Releases | Friday, Jan 28, 2022. (n.d.). Retrieved March 10, 2022, from https://www.gene.com/media/press-releases/14943/2022-01-28/fda-approves-genentechs-vabysmo-the-firs
[10] Bryn Mawr Communications. (2022, January 29). FDA approves Genentech's Vabysmo, the first bispecific antibody for the eye, to treat wet AMD and DME. Eyewire+. Retrieved March 27, 2022, from https://eyewire.news/news/fda-approves-genentechs-vabysmo-the-first-bispecific-antibody-for-the-eye-to-treat-wet-amd-and-dme?c4src=article%3Ainfinite-scroll
[11] Vonjo (pacritinib). CenterWatch RSS. (n.d.). Retrieved March 10, 2022, from https://www.centerwatch.com/directories/1067-fda-approved-drugs/listing/4776-vonjo-pacritinib
[12] Kansteiner, F. (2022, March 1). CTI BioPharma Clinches Long-awaited FDA approval for myelofibrosis blockbuster prospect vonjo. Fierce Pharma. Retrieved March 27, 2022, from https://www.fiercepharma.com/pharma/cti-clinches-long-awaited-approval-myelofibrosis-blockbuster-waiting-vonjo
[13] FDA approves Enjaymo™ (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease. https://www.sanofi.com/en/media-room/press-releases/2022/2022-02-04-23-00-00-2379517. (2022, February 4). Retrieved March 27, 2022, from https://www.sanofi.com/en/media-room/press-releases/2022/2022-02-04-23-00-00-2379517
[14] Center for Drug Evaluation and Research. (n.d.). FDA approves treatment for adults with rare type of anemia. U.S. Food and Drug Administration. Retrieved March 11, 2022, from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-rare-type-anemia
[15] PYRUKYND (mitapivat), FDA Approved for Treatment of Hemolytic Anemia in Adults with Pyruvate Kinase Deficiency, Available Exclusively at Biologics by McKesson. McKesson. (2022, March 2). Retrieved March 11, 2022, from https://www.mckesson.com/About-McKesson/Newsroom/Press-Releases/2022/PYRUKYND-FDA-Approved-Treatment-Hemolytic-Anemia/
[16] Center for Drug Evaluation and Research. (2022, February 17). FDA approves treatment for anemia in adults with rare inherited disord. U.S. Food and Drug Administration. Retrieved March 27, 2022, from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-anemia-adults-rare-inherited-disorder
[17] Vinluan, F. (2022, February 18). Agios strategy shift pays off with FDA approval of first drug for rare anemia. MedCity News. Retrieved March 27, 2022, from https://medcitynews.com/2022/02/agios-strategy-shift-pays-off-with-fda-approval-of-first-drug-for-rare-anemia/
[18] Adams, B. (2022, February 7). Top 10 most anticipated drug launches of 2022. Fierce Pharma. Retrieved March 27, 2022, from https://www.fiercepharma.com/special-report/10-most-anticipated-drug-launches-202