Traditional Drug Pipeline Monthly Update: November 2023

This monthly pipeline wrap-up provides a review of newly approved specialty drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

See separate article for pipeline information on specialty drugs.

New Drug Information

Voquezna® (vonoprazan): The single agent product Voquezna contains the potassium-competitive acid blocker vonoprazan. It was approved by the United States (U.S.) Food and Drug Administration (FDA) for healing and maintenance of healing of all grades of erosive esophagitis (EE) and relief of heartburn associated with EE. It is also approved for use in combination with amoxicillin ± clarithromycin for the treatment of Helicobacter pylori infection.[1] Voquezna is administered orally once daily with dose and duration of therapy dependent on the indication. In clinical trials, vonoprazan was noninferior to lansoprazole in healing of EE and was superior to lansoprazole for maintenance of healing of EE. Phathom Pharmaceuticals plans to launch Voquezna in the U.S. in December 2023, with pricing to follow.[2]

 Zituvimet (sitagliptin/metformin): The FDA approved Zituvimet by Zydus Lifesciences, a fixed-dose combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide.[3] It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). Zituvimet was approved through the 505(b)(2) pathway with Janumet® (sitagliptin/metformin) as the reference product. The formulation has undergone quality testing and is compliant with current FDA standards for nitrosamines, a human carcinogenic impurity, that has been found in other sitagliptin-containing medications. As with other sitagliptin-containing medications, Zituvimet carries a boxed warning for lactic acidosis. Market availability of Zituvimet has yet to be announced with pricing information to follow.

 Zepbound™ (tirzepatide): Under a Priority Review, the FDA approved Eli Lilly’s Zepbound for chronic weight management in adults with obesity (body mass index [BMI] ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with ≥ 1 weight-related comorbid condition (e.g., hypertension, dyslipidemia, T2DM, obstructive sleep apnea or cardiovascular [CV] disease). It is to be used in addition to a reduced calorie diet and increased physical activity. Zepbound is the first medication indicated for weight management that targets both the glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors. After dose titration, the recommended target dose of Zepbound for weight management is 5 mg, 10 mg, or 15 mg self-administered subcutaneously  once weekly. Approval was based on two published, phase 3, 72-week trials: SURMOUNT-1 (NCT04184622; patients without T2DM) and SURMOUNT-2 (NCT04657003; patients with T2DM) which were conducted in conjunction with counseling, a reduced-calorie diet and increased physical activity, in patients with obesity or overweight and with ≥ 1 weight-related comorbidity.[4],[5]  Both trials reported significant dose-dependent weight loss (SURMOUNT-1: −15% [5 mg dose], −19.5% [10 mg dose], −20.9% [15 mg dose] versus −3.1% with placebo; SURMOUNT-2: –12.8% [10 mg dose] and –14.7% [15 mg dose] versus –3.2% with placebo). Like other GLP-1 receptor agonists, Zepbound carries a boxed warning for risk of thyroid C-cell tumors and is contraindicated for use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). Tirzepatide is also approved as Mounjaro® for the treatment of T2DM, with maintenance doses ranging from 5 mg to 15 mg SC once weekly. Zepbound is anticipated to be available in the U.S. in 2023, as prefilled single-dose pens in 6 dosage strengths (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg). Other injectable GLP-1 receptor agonists approved for weight loss include Wegovy® (semaglutide) and Saxenda® (liraglutide), which are indicated for use in adults and adolescents 12 years and older. Eli Lilly has announced a list price of $1,059.87, which is 20% lower than Wegovy 2.4 mg.[6] Weight loss drugs are not covered by Centers for Medicare and Medicaid Services (CMS).

Generic Drug Information

CaroSpir® (spironolactone) 25 mg/5mL oral susp: Amneal Pharmaceuticals launched their generic version of CMP Pharma’s CaroSpir for the treatment of heart failure, hypertension, or edema caused by cirrhosis. Hetero is anticipated to launch their generic version in 2025. No other generics are pending FDA approval. CaroSpir generated $14 million in U.S. annual sales in 2022.

Mitigare® (colchicine) 0.6 mg capsule: Par Pharmaceuticals/Endo Pharmaceuticals launched their generic version of Hikma Specialty USA’s Mitigare for the treatment of prophylaxis of gout flares. Multiple generic manufacturers are expected to launch their generic versions in 6 months. Mitigare generated $59 million in U.S. annual sales in 2022.

Livalo®  (pitavastatin) 1 mg, 2 mg, 4 mg: Multiple manufacturers launched their generic version of Kowa Pharmaceuticals’ Livalo to reduce low-density lipoptrotein cholesterol. Livalo generated $345 million in U.S. annual sales in 2022.

References

[1] Voquezna labeling: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215151s000lbl.pdf.

[2] Press release. https://investors.phathompharma.com/news-releases/news-release-details/phathom-pharmaceuticals-announces-fda-approval-voqueznar.

[3] Zituvimet labeling: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216743s000lbl.pdf.

[4] SURMOUNT-1 trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2206038?articleTools=true.

[5] SURMOUNT-2 trial: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01200-X/fulltext.

[6] Press Release. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-zepboundtm-tirzepatide-chronic-weight.