The European Commission has approved AbbVie’s Aquipta as migraine prophylaxis for adult patients, making it the first daily oral treatment of its class to be approved in the EU for the prevention of both chronic and episodic migraines. Several calcitonin gene-related peptide (CGRP) antibodies are administered subcutaneously or via intravenous infusions. But there is a preference among patients for oral therapies, says Dawn Carlson, vice president, Neuroscience Development at AbbVie, in an interview with Pharmaceutical Technology. Lundbeck’s CGRP antibody Vyepti (eptinezumab), is administered through intravenous infusions, while Amgen’s Aimovig (erenumab) is injected subcutaneously. The approval of Aquipta is based on the results of the two Phase III studies—ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which both met their primary endpoint of a statistically significant reduction in mean monthly migraine days versus placebo, per the 17 August announcement. In the PROGRESS trial, patients in the 60mg Aquipta cohort reported a 6.8-day reduction in ...
Sandoz, a Novartis division, has announced the US launch of its citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) – a biosimilar version of AbbVie’s Humira (adalimumab). Hyrimoz HCF (100mg/mL) is approved to treat all indications that are no longer covered by the reference medicine regulatory exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Biosimilars, according to the US Food and Drug Administration (FDA), are biological products that are highly similar to an existing FDA-approved reference product. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower healthcare costs. Hyrimoz was approved by the FDA in 2018 at a concentration of 50mg/mL. The HCF offers a 50% reduction compared to the original concentration and can decrease the number of injections required for people who need at least 80mg ...
Merely a month into an FDA approval, AbbVie and Genmab’s bispecific drug Epkinly has chalked up a positive readout that might enable an expansion in blood cancer, although the exact regulatory path remains unclear. Epkinly significantly beat back tumors in 82% of patients with relapsed or refractory follicular lymphoma in a phase 1/2 trial, the companies said Tuesday. The patients had received a minimum two—and a median three—prior lines of systemic therapy. The median duration of response hasn’t been reached in Epkinly’s study, and investigators are still following patients. The companies also didn’t disclose the complete response rate. Full results from the study will be shared at a future medical meeting. Epkinly snagged an FDA approval for previously treated diffuse large B-cell lymphoma (DLCLC) in May, and AbbVie and Genmab said they will talk to regulators about next steps in FL, an indolent form of lymphoma. If approved in the ...
AbbVie announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for its migraine medication Qulipta (atogepant). Once the CHMP has issued a positive opinion, the EMA will send a recommendation to the European Commission (EC) to approve it. While not a guarantee, a positive CHMP opinion is generally a good indication that a drug is likely to be approved. In a June 2023 statement, AbbVie claims that full approval from the European Commission (EC) would position Qulipta as the only daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment for episodic and chronic migraines available in the EU. Qulipta is approved for use in the US. In 2021, it managed to secure FDA approval to treat episodic migraine, receiving further approval this year to also treat chronic migraine. The positive opinion is based on Phase III trial results submitted ...
By Alejandra Manjarrez www.biospace.com Pictured: Judicial gavel and scales of justice/iStock AbbVie has filed a lawsuit accusing China-based BeiGene’s new blood cancer drug Brukinsa (zanubrutinib) of infringing on its patent for Imbruvica (ibrutinib). Imbruvica was co-developed by J&J’s Janssen and AbbVie’s Pharmacyclics and approved in 2014 by the FDA as a treatment for chronic lymphocytic leukemia. Brukinsa, which gained its FDA approval in January 2023, had its patent issued on Tuesday. Through its complaint, filed that same day in federal court in Delaware, AbbVie is seeking a declaratory judgment of infringement plus damages, Bloomberg Law reported. BeiGene’s shares in Hong Kong and mainland China have fallen more than 10% since the announcement. Both Brukinsa and Imbruvica are BTK inhibitors designed as oral medications to treat the slow-growing blood cancers chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). They are different forms of the same disease and account for about ...
AbbVie and Genmab’s blood cancer therapy, Epkinly (epcoritamab-bysp), has been granted accelerated approval by the US Food and Drug Administration (FDA). The authorisation specifically applies to adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least two prior lines of treatment. DLBCL is the most common type of aggressive lymphoma, with approximately 150,000 cases of the disease diagnosed globally each year. For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged, the companies said. However, single agent and ready-available or off-the-shelf treatment options are limited. Epkinly, which is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration, is now the first and only T-cell engaging bispecific antibody for this indication. The FDA’s decision was supported by positive results from a phase 1/2 trial, in which Epkinly delivered an overall response rate of 61%, a complete response rate ...
In developing immunology treatment Rinvoq, AbbVie is employing the same game plan it used to make predecessor Humira a megablockbuster. And the company seems to be getting better at it.Thursday, AbbVie scored its seventh FDA approval for Rinvoq in a span of less than four years, getting the JAK inhibitor across the finish line as a treatment for Crohn’s disease. A look at Humira’s approval history shows that AbbVie has become more efficient in adding indications to its immunology blockbusters. After Humira was initially blessed in 2002, it took AbbVie 10 years to get the TNF blocker endorsed for its seventh disease type. Coincidentally, Rinvoq’s new FDA approval came hours after the U.K.’s National Institute for Health and Care Excellence signed off on the drug for Crohn’s disease. This is the second gastroenterology indication for Rinvoq after it won approval for ulcerative colitis in March of last year. Rinvoq’s first ...
Beth Snyder Bulik Senior Editor AbbVie picked up another indication for blockbuster Rinvoq on Thursday, this time for Crohn’s disease. The seventh FDA approval for the JAK inhibitor is specifically for use in moderate to severe Crohn’s patients who have had inadequate response or intolerance of at least one TNF blocker. While there are several other biologics already on the market to treat moderately to severely active Crohn’s including J&J’s Stelara, Takeda’s Entyvio and AbbVie’s own Skyrizi, the FDA noted that Rinvoq is the first oral drug. The approval was based on results from three studies, the U-EXCEED and U-EXCEL initial trial and the U-ENDURE maintenance trial, determining statistical significance in the co-primary endpoints of endoscopic response and clinical remission. AbbVie consultant and gastroenterologist Edward Loftus, who was a U-EXCEL investigator, said in a news release, “Based on the clinical trial results, treatment with RINVOQ shows both early and long-term ...
Ned PagliaruloLead Editor Dive Brief: AbbVie withstood the first months of U.S. copycat competition to its lucrative arthritis drug Humira about as Wall Street had expected, conceding on price to maintain insurance coverage in response to Amgen launching the country’s first biosimilar rival in January. U.S. Humira sales totaled nearly $3 billion, a decline of 26% from the same period one year ago and just over analysts’ consensus forecasts. AbbVie executives told investors on a Thursday conference call that most of that impact was driven by price changes. Amgen, which recorded $51 million in U.S. revenue for its biosimilar Amjevita, is selling its Humira rival at two different prices: a 5% discount to Humira’s nearly $90,000 annual list price, and a 55% discount. The approach is meant to address the unique demands of the U.S. healthcare system, in which insurers rely on manufacturers providing rebates off of a drug’s sticker ...
The FDA approval of AbbVie’s oral CGRP inhibitor Qulipta in chronic migraine could unleash a fresh phase of growth for the drug. That is the conclusion of survey data gathered by Spherix Global Insights, which found most physicians are very willing to prescribe the drug to patients with chronic migraine. Prior to the FDA approval, Spherix spoke to 74 neurologists and 101 primary care physicians about the migraine market, including their interest in prescribing Qulipta for the treatment of patients who have headaches at least 15 days per month. The survey suggests that AbbVie’s work to drum up interest in Qulipta since winning approval in episodic migraine in 2021 has primed the product for growth. Almost two-thirds of the surveyed neurologists said they would be very willing to prescribe Qulipta to chronic migraine patients, up from half earlier in the launch. Similarly, more than 50% of primary ...
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