11/3/2023 0 Comments Horizon therapeutics tepezza![]() These patients had median duration of TED for 12.9 months versus 6.3 months in those treated with TEPEZZA in OPTIC. As previously reported, 89% (33/37) of patients who received placebo in OPTIC and went on to receive TEPEZZA in OPTIC-X became proptosis responders (average reduction of -3.5 mm). 1Ĭomprehensive results from the OPTIC-X open-label extension clinical trial were published in Ophthalmology – including new long-term data for people with longer disease duration. Food and Drug Administration (FDA) for the treatment of TED – a serious, progressive and potentially vision-threatening rare autoimmune disease. TEPEZZA is the first and only medicine approved by the U.S. The Amgen move on Horizon came shortly after the Irish-domiciled group had established its first in-house manufacturing facility with the takeover of Eirgen’s Waterford plant in a $65 million deal.DUBLIN-( BUSINESS WIRE)-Horizon Therapeutics plc (Nasdaq: HZNP) today announced additional data supporting the long-term efficacy of TEPEZZA for the treatment of TED. “We are unaware of any prior acquisition that has been blocked under a bundling theory,” the company added. Amgen also said the FTC’s claim that it would do this in the future was “entirely speculative”. It said it had already committed to not “bundle” Horizon’s drugs with its own. Tepezza costs approximately $350,000 for a six-month course of treatment while an annual supply of Krystexxa costs $650,000, according to the agency.Īmgen said it was disappointed by the FTC’s decision but remains committed to completing the acquisition. If Amgen were to own these medicines and use its market clout to convince payers to cover them, it could discourage other companies from launching rival medicines that would eventually bring down the price, the FTC said. The FTC argued that Amgen could use the rebates it pays on its existing “blockbuster” drugs to press insurance companies and pharmacy benefit managers into paying for two of Horizon’s medicines: Tepezza for an autoimmune condition that affects the eyes and Krystexxa for a rare type of gout. ![]() Large pharmaceutical companies are sitting on piles of cash that many plan to spend on deals for innovative drugs to replenish their pipelines as existing treatments go off patent. Regeneron claims Amgen incentivised payers to buy its drugs by “bundling” it with other popular treatments.Īmgen declined to comment on Mr Schleifer’s remarks. Regeneron is in a long-running legal dispute with Amgen centred on accusations the company violated antitrust laws in the way it marketed a cholesterol drug. “In some respects, the worst thing for our industry and we’ve got to shine a brighter light on it.” “I’m glad the FTC is looking at this,” Mr Schleifer told the Financial Times US Pharma and Biotech Summit in New York. Drugmakers pay rebates to ensure their treatment is placed on the lists of drugs covered by insurance companies. Mr Schleifer said it can be hard to for a drugmaker get a treatment covered by payers if they are receiving “billions and billions of dollars” in rebates from a rival company. However, the FTC’s case against Amgen is targeted at the power the company allegedly wields more broadly with health insurers and middlemen in the US healthcare system, known as pharmacy benefit managers. In the past, regulators have tended to focus their energies on drugmakers that try to corner the market by buying up lots of medicines that treat the same disease. It was seen as giving the US group a new pipeline of drugs for rare autoimmune and inflammatory diseases as well as adding a blockbuster drug to Amgen’s portfolio and helping to counter the impact from rising competition for its top-selling arthritis drug, Enbrel, from newer treatments and the expected expiry of patents for the therapy in 2029. The Federal Trade Commission (FTC) warned that “rampant consolidation” in the pharmaceutical sector was pushing up prices for patients as it filed the lawsuit against the Amgen deal.Īmgen won out in a three-way tussle with Sanofi and Johnson & Johnson when it announced what was the biggest pharmaceutical deal of the year last December, and the largest to date for Amgen. The chief executive of Regeneron has backed an attempt by US regulators to block Amgen’s $28 billion (€25.85 billion) acquisition of Irish-headquartered rare disease specialist Horizon Therapeutics, as he accused some pharmaceutical companies of abusing their market power to prevent competition.
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