FDA

FDA Adds CLL/SLL to Brukinsa’s Label

The FDA recently gave an additional approval to BeiGene, Ltd.’s Brukinsa (zanubrutinib), which is already approved for three other rare types of non-Hodgkin lymphoma. Respondents to a Zitter Insights survey said that while its availability will result in a lower level of unmet need in the treatment of chronic lymphocytic leukemia (CLL), there is still moderate or high unmet need for the condition.

On Jan. 19, the FDA expanded the label of Brukinsa to include the treatment of adults with CLL or small lymphocytic lymphoma (SLL). CLL and SLL are the same disease, a type of non-Hodgkin lymphoma, except CLL cancer cells are mostly in the blood and bone marrow, while in SLL, the cells are mainly in the lymph nodes.

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Like Aduhelm, Leqembi Faces Cost, Efficacy Concerns

Two Alzheimer’s disease drugs developed by Biogen Inc. — Aduhelm (aducanumab) and Leqembi (lecanemab-irmb), which are both meant to attack the buildup of amyloid plaque in the brain — have been met with skepticism by providers and payers. A new report by Tufts University researchers found that few commercial carriers cover Aduhelm, while the Institute for Clinical and Economic Review (ICER) concluded that Leqembi’s high price exceeds its expected clinical value — and one expert says that neither finding is surprising, given the controversies surrounding both drugs.

The FDA on March 6 said that Leqembi, which Biogen developed in a joint venture with Eisai Co., Ltd., will have a full approval decision by July 6. In February, the agency granted Leqembi priority review; the drug gained an accelerated approval designation in January. Aduhelm, meanwhile, garnered accelerated approval in June 2021, despite broad controversy. Aduhelm's accelerated approval was broadly denounced by practitioners, and the HHS Office of Inspector General is investigating improper contacts between FDA staff and Biogen.

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News Briefs: FDA Accepted Application for Sanofi’s Biosimilar Denosumab

The FDA accepted its first application for a biosimilar denosumab, Sandoz disclosed on Feb. 6. The Amgen Inc. reference drug is available as both Prolia and Xgeva. According to AmerisourceBergen’s Feb. 6 U.S. Biosimilar Report, nine companies have denosumab biosimilars in clinicals trials, with five of those in Phase III trials. Prolia and Xgeva are approved for multiple conditions, including for the treatment of postmenopausal women with osteoporosis at high risk for fracture and for the prevention of skeletal-related events in people with multiple myeloma and in people with bone metastases from solid tumors. Sandoz’s application is for all of the drugs’ indications. Prolia’s list price is $1,564.31 per injection every six months, and the per-dose price for Xgeva — which is dosed every four weeks — is $2,877.36.

Elevance Health said on Feb. 15 that it had closed its acquisition of BioPlus, a specialty pharmacy subsidiary of CarepathRx, a portfolio company of Nautic Partners. BioPlus will operate as part of CarelonRx, Elevance’s PBM within Carelon, its health care services brand. Elevance said Nov. 9 that it had entered into an agreement to purchase the company. It did not disclose financial terms of the deal. The firm also said that it “plans to expand BioPlus’ service models across more complex disease treatment areas so the combined company can continue to provide timely access to medications, deliver leading support services for both providers and patients, and ensure individuals receive distinctive clinical expertise and service.

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Payers May Be Slow to Embrace Nexletol as Next Best Step After Statins

At the American College of Cardiology’s annual meeting in New Orleans, Esperion Therapeutics, Inc., presented data from a highly anticipated clinical trial that shows its cholesterol-lowering drug Nexletol (bempedoic acid) can reduce the risk for heart attack, stroke and other serious cardiac events. Company executives say the results position bempedoic acid as the logical next step for patients who can’t or won’t tolerate statins. Yet some pharmacy benefits experts say it may be a while before the therapy makes a major dent in the market.

“If any impact is seen, it may be slow as the results of the studies were recently released over the weekend,” Mesfin Tegenu, chairman and CEO of RxParadigm, Inc., tells AIS Health, a division of MMIT. “In theory, there would be an increase in uptake for patients with an established atherosclerotic vascular disease and in those at high risk for vascular disease who are unable or unwilling to take statins,” he adds. “However, coverage may continue to be slow until the data is fully analyzed.”

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New FDA Approvals: FDA Expands Patient Population of Takeda’s Takhzyro

Feb. 3: The FDA expanded the patient population for Takeda’s Takhzyro (lanadelumab-flyo) to include the prevention of hereditary angioedema attacks in people at least 2 years old. The agency initially approved the plasma kallikrein inhibitor on Aug. 3, 2018. Dosing of the subcutaneous injectable in people at least 12 years old is 300 mg every two weeks. In people at least 6 and less than 12, dosing is 150 mg every two weeks, and for people 2 years old and younger than 6, dosing is 150 mg every four weeks. Drugs.com lists the price of one single-dose 300 mg/2 mL subcutaneous solution as more than $26,165.

Feb. 8: The FDA granted another indication to Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept) for the treatment of retinopathy of prematurity in preterm infants. The agency first approved the drug on Nov. 18, 2011. Dosing of the vascular endothelial growth factor (VEGF) inhibitor for the newest indication is 0.4 mg via intravitreal injection; treatment may be given bilaterally on the same day. Injections may be repeated with an interval of at least 10 days. Drugs.com lists the price of a 40 mg/ml intravitreal solution as more than $1,957.

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News Briefs: Covis Pharma to Pull Makena

Covis Pharma Group said on March 7 that it will voluntarily stop selling Makena (hydroxyprogesterone caproate), a drug that aims to reduce preterm births and that has become a flashpoint in the debate over the FDA’s accelerated approval pathway. Makena was granted accelerated approval in 2011, but subsequent clinical trials failed to demonstrate its effectiveness, leading FDA advisers last fall to recommend withdrawing the drug from the market. “While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” Covis Chief Innovation Officer Raghav Chari, Ph.D., said in a statement. The move comes ahead of an anticipated final decision on Makena’s status by FDA Commissioner Robert Califf and Chief Scientist Namandjé Bumpus.

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News Briefs: Judge Bars CVS From Poaching Cigna Exec

A Missouri federal judge barred former Cigna Group executive Amy Bricker from moving to CVS Health Corp., finding that Bricker’s planned move would violate her noncompete agreement with Cigna, where she led the Express Scripts PBM. Cigna sued to block Bricker from leaving the company, arguing that Bricker’s knowledge of trade secrets and the firm’s “most highly sensitive information” would aid CVS in direct competition with Cigna. Bricker countered that her new CVS role was not meant to encompass pharmacy benefits and would not have involved any work with CVS’s Caremark PBM division. Earlier this year, the Biden administration announced an effort to ban noncompete clauses in employment agreements.

The number of independent pharmacists remained relatively flat in 2023, according to a survey by the Pharmaceutical Care Management Association (PCMA), a PBM trade group, with 23,353 independent pharmacies in operation across the U.S. The number of independent pharmacies increased by 99 between January 2022 and January 2023, a 0.4% uptick that nearly matches the 0.5% five-year trend, the survey found. Over the past 10 years, the number of independent pharmacies has grown by 7.5%.

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Tezspire’s New Self-Administration Labeling Could Bring Higher Market Share

The FDA on Feb. 2 granted approval for a self-administered version of Amgen Inc. and AstraZeneca plc’s Tezspire (tezepelumab-ekko), a biologic used as a preventive maintenance therapy for severe asthma. Pharmacy experts tell AIS Health, a division of MMIT, that the drug’s high price tag and high clinical thresholds mean that adoption is unlikely to spike in the short term.

The new version of Tezspire, a human monoclonal antibody, can be self-administered by patients through a pre-filled pen. Doses last four weeks. Tezspire is “the only biologic approved for severe asthma with no phenotype (e.g., eosinophilic or allergic) or biomarker limitation within its approved label,” per an Amgen press release. It was first approved in December 2021, But previously, the drug had to be administered by a practitioner.

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2023 Outlook: Humira Is Not Only Specialty Drug With Anticipated Biosimilars

One of the biggest events in the specialty pharmacy market is happening this year: the availability of biosimilars to AbbVie Inc.’s top-selling Humira (adalimumab). With its Jan. 31 launch, Amgen Inc.’s Amjevita (adalimumab-atto) was the first entrant, and others are expected this summer. But biosimilars of other top biologics also are coming down the pike. AIS Health, a division of MMIT, spoke with a variety of industry experts about what they’re watching in this space in 2023.

AIS Health: What kind of impact will be seen from the Humira biosimilars?

Nicole Kjesbo, Pharm.D., director of clinical program development for Prime Therapeutics LLC: Ideally, we’ll see price competition due to multiple biosimilars of Humira launching in 2023.

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News Briefs: AstraZeneca Will Withdraw Lumoxiti From the U.S. Market

AstraZeneca will permanently withdraw Lumoxiti (moxetumomab pasudotox-tdfk) from the U.S. market, the company revealed recently. In a letter to health care providers, the company said it will direct its distributors to halt distribution of the agent in August 2023 and will request that those distributors return any Lumoxiti packs. The FDA approved the medication on Sept. 13, 2018, for the treatment of relapsed or refractory hairy cell leukemia in people who had received at least two prior systemic therapies including a purine nucleoside analog. The manufacturer said that the drug’s withdrawal is not related to its safety or efficacy and that the medicine has had “very low clinical uptake” since its approval, “due to the availability of other treatment options and possibly due to the specialized complexity of administration, toxicity prophylaxis and safety monitoring needs for patients.” The company advised providers not to start treatment of the drug. For patients already taking it, providers have “adequate time to complete six cycles of treatment.”

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