Specialty Drugs

FDA Approves Gilead’s First-in-Class HIV Drug Sunlenca

The FDA recently approved a new HIV drug for a small patient population desperately in need of treatments. And the twice-yearly medication’s annual price came below the level that respondents to a Zitter Insights poll said they would consider a good value.

On Dec. 22, the FDA approved Gilead Sciences, Inc.’s Sunlenca (lenacapavir) for the treatment, in combination with other antiretroviral(s), of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The agency gave the first-in-class capsid inhibitor priority review, fast track and breakthrough therapy designations.

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New Organization Will Focus on Medical Benefit Drugs

A group of Blue Cross and Blue Shield-affiliated companies recently unveiled a new medication contracting organization focused on medical benefit drugs. The new company, known as Synergie Medication Collective, will be successful in improving the affordability of these treatments and patients’ access to them, an industry expert says, but it also will need to show that patients are seeing those savings.

Unveiled Jan. 5, the company says it “is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans.” It will focus not only on infusible treatments for conditions such as cancer but also on multimillion dollar gene therapies. The company says its goal is to “significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders.” It plans to “bring to market several new product offerings” this year, among them “transformative value-based models.”

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For Now, New Alzheimer’s Treatment Is Subject to Limited Medicare Coverage

Marking the second approval of an Alzheimer’s disease treatment aimed at slowing cognitive decline by reducing amyloid plaque buildup on the brain, the FDA on Jan. 6 granted accelerated approval to Biogen and Eisai, Co., Ltd.’s Leqembi (lecanemab-irmb). For now, the drug remains subject to the restrictive National Coverage Determination that Medicare initially gave its predecessor, Aduhelm (aducanumab-avwa), and similar Alzheimer’s treatments last year, but CMS could consider broader coverage if the drug receives traditional FDA approval.

The drug is indicated for the treatment of Alzheimer’s disease in people with mild cognitive impairment or mild dementia. Patients must have confirmed presence of amyloid beta pathology before starting treatment. The FDA gave the humanized immunoglobulin gamma 1 monoclonal antibody fast track, priority review and breakthrough therapy designations. Japanese pharmaceutical company Eisai developed the drug and will co-market it with its U.S. partner Biogen, which launched Aduhelm in 2021 and had to halve its price from $56,000 a year to $28,000. Eisai estimates the cost of Leqembi will be $26,500 per year, though the actual price could vary by patient.

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New FDA Approvals: FDA Gives Accelerated Approval to Mirati’s Krazati

Dec. 12: The FDA gave accelerated approval to Mirati Therapeutics, Inc.’s Krazati (adagrasib) for the treatment of adults with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test (see below brief), who have received at least one systemic therapy. Dosing for the tablet is 600 mg twice daily. The drug is priced at $19,750 per month.

Dec. 12: The FDA approved two companion diagnostics for Krazati (see above brief): Agilent Technologies Inc.’s Agilent Resolution ctDx FIRST assay and Qiagen N.V.’s Qiagen therascreen KRAS RGQ PCR kit. A liquid biopsy next-generation sequencing assay, the Agilent test detects genomic alterations in circulating tumor DNA from plasma. The Qiagen test, first approved July 6, 2012, is a tissue-based assay.

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FDA Approved Four New Gene Therapies, Other Novel Agents in 2022

While the FDA may not have approved the most drugs in a year in 2022, it still gave the green light to a number of agents, many of them specialty medications, as well as granted additional indications to existing therapies. The FDA’s Center for Drug Evaluation and Research (CDER) approved 39 new molecular entities in 2022, and the Center for Biologics Evaluation and Research (CBER) approved 12 biologic license applications, including four new gene therapies in the second half of the year. AIS Health, a division of MMIT, asked some industry sources what the most notable 2022 FDA approvals were and why they were so important.

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New Organization Will Focus on Medical Benefit Drugs

A group of Blue Cross and Blue Shield-affiliated companies recently unveiled a new medication contracting organization focused on medical benefit drugs. The new company, known as Synergie Medication Collective, will be successful in improving the affordability of these treatments and patients’ access to them, an industry expert says, but it also will need to show that patients are seeing those savings.

Unveiled Jan. 5, the company says it “is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans.” It will focus not only on infusible treatments for conditions such as cancer but also on multimillion dollar gene therapies. The company says its goal is to “significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders.” It plans to “bring to market several new product offerings” this year, among them “transformative value-based models.”

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News Briefs: FDA Requests Withdrawal of Pepaxto Marketing Authorization

The FDA has requested that Oncopeptides AB withdraw the U.S. marketing authorization for Pepaxto (melphalan flufenamide), the company revealed on Dec. 7. “We respect FDA´s accelerated approval regulations,” said CEO Jakob Lindberg in a statement. The FDA initially gave the therapy accelerated approval on Feb. 26, 2021, in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody. But then on Oct. 22, 2021, the company requested voluntary withdrawal of the peptide-drug conjugate’s New Drug Application (NDA). That was followed early in 2022 by Oncopeptides’ rescinding the letter requesting the NDA’s withdrawal based on “further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study and other relevant trials.” On Sept. 22, 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) held a meeting to assess the drug’s risk/benefit profile; it voted 14-2 that the drug is not favorable for adults with relapsed or refractory multiple myeloma. Oncopeptides is commercializing the therapy in Europe, where it is known as Pepaxti, following its full approval on Aug. 18, 2022.

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FDA Approves Alzheimer’s Agent Leqembi Shortly After Release of Congressional Aduhelm Report

Less than two years after the FDA approved the first treatment for Alzheimer’s that was aimed at targeting the underlying disease process, it has approved a second similar agent. Payers are likely to cover the drug, one industry expert says, but they almost certainly will try to place restrictions on their coverage.

On Jan. 6, the FDA gave accelerated approval to Eisai Co., Ltd. and Biogen Inc.’s Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease in people with mild cognitive impairment or mild dementia stage of disease. People must have confirmed presence of amyloid beta pathology before starting treatment. The agency gave the humanized immunoglobulin gamma 1 monoclonal antibody fast track, priority review and breakthrough therapy designations.

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2022 Saw Continued Approvals, Uptake of Biosimilars

Following the FDA’s March 6, 2015, approval of the first biosimilar in the United States — Zarxio (filgrastim-sndz) from Novartis Pharmaceuticals Corp.’s Sandoz unit — these agents have continued to gain market share, even though not all that have been approved have launched. And while the European Union approved its first biosimilar, Sandoz’s Omnitrope (somatropin), almost a decade earlier on April 12, 2006, the U.S. outpaced the EU in biosimilar approvals in the eight-year post-launch period 40 to 15. Last year continued the trend, with the FDA approving seven new biosimilars. AIS Health, a division of MMIT, asked some industry experts about the agents’ impact over the past year.

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2023 Outlook: PBMs Will Focus on Humira Biosimilars, Specialty Drug Spend, FTC Probe

For the past few years, PBMs and plan sponsors have waited for the arrival of Humira (adalimumab) biosimilars. The first such product, Amgen’s Amjevita, is expected to hit the market on Jan. 31, more than six years after the FDA approved the drug. The agency has approved seven other Humira biosimilars, some of which are expected to become available next year, as well.

The competition means AbbVie, Humira’s manufacturer, will no longer have a monopoly on the drug category, which generated $13.6 billion in revenue in the U.S. during the first nine months of 2022, up 6.5% from the same time period in 2021.

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