Drug Approvals

FDA Approves First Multiple Sclerosis Biosimilar, Sandoz’s Tyruko

The FDA recently approved the first biosimilar for the treatment of multiple sclerosis (MS): Tyruko (natalizumab-sztn) from Novartis Pharmaceutical Corp. subsidiary Sandoz Inc. The drug is entering a fairly crowded class, and payers have said they expect it to have a moderate impact on their management of the other agents available to treat the condition.

On Aug. 24, the FDA approved Tyruko for the treatment of two indications: (1) adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, and (2) adults with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn’s therapies and tumor necrosis factor (TNF) inhibitors.

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FDA Broadens Lonsurf Use in Colorectal Cancer

The FDA recently granted another approval to Taiho Pharmaceutical Co., Ltd. Division Taiho Oncology, Inc.’s Lonsurf (trifluridine/tipiracil) in combination with another agent for a type of colorectal cancer. The decision provides another treatment option for a condition that respondents to a Zitter Insights survey regard as in need of more effective therapies.

On Aug. 2, the FDA approved Lonsurf as a single agent or in combination with bevacizumab for the treatment of adults with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) drug and, if Rat sarcoma (RAS) wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. Bevacizumab originally was available as Avastin from Genentech USA, Inc., a member of the Roche Group, but now four biosimilars of it are also on the market: Celltrion USA, Inc.’s Vegzelma (bevacizumab-adcd), Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly), Pfizer Inc.’s Zirabev (bevacizumab-bvzr) and Amgen Inc.’s Mvasi (bevacizumab-awwb).

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New FDA Approvals: FDA Gives Accelerated Approval to J&J’s Talvey

Aug. 9: The FDA gave accelerated approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Talvey (talquetamab-tgvs) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The review was conducted under Project Orbis in collaboration with the Australian Therapeutic Goods Administration and Switzerland’s Swissmedic; it used the Assessment Aid. The agent, a G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CD3 T-cell engager, is a first-in-class bispecific antibody. Dosing of the subcutaneous injection, which is administered by a qualified health care professional, can be done weekly or biweekly. For weekly dosing, a step-up schedule consists of 0.01 mg/kg on day one, then 0.06 mg/kg on day four, then 0.4 mg/kg on day seven and then 0.4 mg/kg one week later and weekly thereafter. For biweekly dosing, administration starts at 0.01 mg/kg on day one, 0.06 mg/kg on day four, 0.4 mg/kg on day seven, then 0.8 mg/kg on day 10 and then 0.8 mg/kg two weeks later and every two weeks thereafter. The drug’s list price is $45,000 per month, and the company estimates a pricing range of $270,000 to $360,000 for an average treatment duration of six to eight months.

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Payers Are Reluctant to Offer Commercial Coverage for Alzheimer’s Drug Leqembi

When the FDA in July granted full approval to the Alzheimer’s drug Leqembi (lecanemab), CMS followed with a swift announcement that Medicare will cover it — although just for people with a specific diagnosis who have a physician willing to participate in a qualifying clinical registry. However, payers so far seem reluctant to cover the drug for their commercially insured populations, which represent a smaller but still important portion of the addressable market for Leqembi.

Two Pennsylvania-based insurers — Highmark Inc. and Independence Blue Cross — are taking heat for deciding not to cover the drug for their commercial members. A Philadelphia-area neurology practice recently sent them a critical open letter that claims the insurers are wrong to deem Leqembi “experimental.”

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News Briefs: CVS Launches Biosimilar-Focused Subsidiary

CVS Health Corp. on Aug. 23 launched a subsidiary called Cordavis, which will work with drug manufacturers to “commercialize and/or co-produce biosimilar products.” CVS said it has contracted with Sandoz to bring Hyrimoz, a Humira biosimiliar, to market in the first quarter of 2024 under a private Cordavis label. The list price of Cordavis Hyrimoz, the company said, will be “more than 80% lower than the current list price of Humira.” Sandoz launched a branded, high-concentration formulation of Hyrimoz on July 1, joining several other Humira biosimilars that launched in the same month.

On Aug. 21, Pfizer Inc.’s Abrysvo became the first vaccine approved by the FDA for use in pregnant people to prevent respiratory syncytial virus (RSV) in infants. The vaccine, which is administered in one dose, is approved for use at 32 through 36 weeks gestational age of pregnancy, and it can prevent lower respiratory tract disease caused by RSV in infants from birth through six months old. In May, the FDA approved Abrysvo for the prevention of lower respiratory tract disease cause by RSV in people age 60 and older. The FDA in July approved AstraZeneca and Sanofi’s Beyfortus (nirsevimab-alip) for preventing RSV in infants, and the Centers for Disease Control and Prevention in early August recommended the vaccine be given to all infants under 8 months and some older babies at increased risk of severe illness starting this fall.

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FDA Approves New Colorectal Cancer Treatment

The FDA recently granted another approval to Taiho Pharmaceutical Co., Ltd. division Taiho Oncology, Inc.’s Lonsurf (trifluridine/tipiracil) for a type of colorectal cancer. The decision provides another treatment option for a condition that respondents to a Zitter Insights survey regard as in need of more effective therapies.

On Aug. 2, the FDA approved Lonsurf as a single agent or in combination with bevacizumab for the treatment of adults with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) drug and, if Rat sarcoma (RAS) wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The agency first approved the oral nucleoside antitumor agent on Sept. 22, 2015. The newest use had priority review. Dosing for the tablet is 35 mg/m2 twice daily on days one through five and days eight through 12 of each 28-day cycle. Drugs.com lists the price of 20 6.14 mg/15 mg tablets as more than $4,204.

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New FDA Approvals: FDA Expands Label of Novartis’ Leqvio

July 7: The FDA broadened the label of Novartis Pharmaceuticals Corp.’s Leqvio (inclisiran) to include its use as an adjunct to diet and statin therapy to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. The agency initially approved the small interfering RNA (siRNA) therapy on Dec. 22, 2021. Dosing is 284 mg via a subcutaneous injection by a health care professional, then another dose at three months and then every six months. The drug’s list price is $3,290.63 per dose.

July 11: The FDA expanded the label of Organon’s Hadlima (adalimumab-bwwd) to include the treatment of adults with non-infectious intermediate and posterior uveitis and panuveitis. The agency first approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) on July 23, 2019. Dosing starts with 80 mg via subcutaneous injection, followed by 40 mg every other week starting one week after the initial dose. The agent is available in both low-concentration and high-concentration versions of its reference drug. The product recently launched with a wholesale acquisition cost of $1,038 for a carton of two syringes or autoinjectors.

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News of Wegovy’s Cardiac Benefits Could Make Coverage More Compelling

Demand for Novo Nordisk A/S’s Wegovy (semaglutide) may spike even higher following the Danish pharma giant’s Aug. 8 announcement that the diabetes drug, recently approved by the FDA for use as a weight loss treatment, “reduces the risk of major adverse cardiovascular events by 20%” in patients with obesity. Clinicians and pharmacists say the drug’s broad appeal became even greater with the news but suggest that insurers and plan sponsors are likely to continue to erect access barriers to Wegovy given its high cost and clinical limitations.

Novo said a double-blinded trial “compared subcutaneous once-weekly semaglutide 2.4 mg with placebo as an adjunct to standard of care for prevention of major adverse cardiovascular events (MACEs) over a period of up to five years,” and “achieved its primary objective by demonstrating a statistically significant and superior reduction in MACE of 20% for people treated with semaglutide 2.4 mg compared to placebo.”

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Newer Drugs for ALL Are Hitting the U.S. Market, Potentially Meeting Unmet Need in Treatment

The FDA has approved multiple new agents for the treatment of acute lymphoblastic leukemia (ALL) — which is also known as acute lymphocytic leukemia — and recently converted an accelerated approval it had given one of them to full. However, even with all these options, respondents to a Zitter Insights survey said that unmet need exists in treating the disease.

On June 21, 2023, the FDA granted full approval to Amgen Inc.’s Blincyto (blinatumomab) for the treatment of adults and pediatric patients with CD19-positive B-cell precursor ALL first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. The agency first approved the CD19-directed CD3 T-cell engager on Dec. 3, 2014; the accelerated approval for MRD-positive B-cell ALL was granted on March 29, 2018.

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PSG Report Shows Double-Digit Specialty Drug Trend, but Opportunities for Savings Exist

Specialty drug trend continues to be in consistent double digits, with increases due to both spend and trend. That’s one of the findings of the 2023 Artemetrx Specialty Spend & Trend Report from the Pharmaceutical Strategies Group (PSG), an EPIC company. And with the specialty drug pipeline continuing to pump out more and more expensive agents, opportunities for savings exist through the use of biosimilars and generic specialty drugs, among other strategies.

Published July 25, the report is sponsored by Walmart Specialty Pharmacy and includes data from 2022. Findings are based on an analysis of 347 million medical claims and 133 million pharmacy claims from PSG’s Artemetrx book of business. Artemetrx is a proprietary SaaS platform developed by PSG. This is the seventh annual version of the report, which started under the Pharmacy Benefit Management Institute (PBMI) moniker. In April 202, MJH Life Sciences acquired PBMI’s trademarks, conference, website, education and membership assets, while the current and future research and analytics projects remained with PSG.

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