Vilanterol Trifenatate

Pictured: Entrance to the FTC's office in Washington, DC/iStock, hapabapa The U.S. Federal Trade Commission on Tuesday sent warning letters to 10 pharmaceutical companies, challenging patents for several drugs including Novo Nordisk’s blockbuster diabetes treatment Ozempic (semaglutide) and GSK’s asthma inhaler Trelegy Ellipta (fluticasone, umeclidinium, vilanterol). The FTC is challenging the patents of 20 different brand name products, claiming that their listings in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations—more commonly known as the Orange Book—are improper or inaccurate. “By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” FTC Chair Lina Khan said in a statement. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need,” Khan added. In addition to Ozempic and Trelegy Ellipta, the FTC’s latest round of patent challenges also targets Novo’s Saxenda (liraglutide) and Victoza (liraglutide)—both indicated for type 2 diabetes—and Novartis’ inhaler products Seebri Breezhaler (glycopyrronium bromide) and Utibron Neohaler (indacaterol and glycopyrrolate), approved for chronic obstructive pulmonary disease. The pharma companies now have 30 days to either withdraw or amend their disputed listings, or confirm “under penalty or perjury” that these patents indeed comply with the statutory and regulatory requirements. A GSK spokesperson in a statement to Endpoints News said that the company is reviewing the FTC’s letter. GSK takes “the FTC’s views seriously; however, we will also do our own analysis as the law requires. Once complete, we will respond to the FDA and FTC.” Meanwhile, a Boehringer Ingelheim spokesperson said that the pharma “has never wrongfully submitted patents for listing in the Orange Book.” Tuesday’s warnings follow an initial salvo in November 2023, when the FTC challenged more than 100 patents by 10 pharma companies including AbbVie, AstraZeneca and subsidiaries of GSK and Teva Pharmaceuticals. At the time, the antitrust watchdog targeted a wide range of pharmaceutical products, including inhaler devices, multidose bottles and epinephrine autoinjectors. Aside from the FTC, members of Congress have also started targeting the high cost of medication in the U.S., paying particular attention to Ozempic. Last week, Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, launched a probe into the ‘outrageously high prices’ of Ozempic, as well as its sister weight-loss therapy Wegovy (semaglutide). Sanders in a letter to Novo CEO Lars Fruergaard Jørgensen asked for additional information regarding Ozempic and Wegovy, including revenue, prices paid by public and private payers, R&D spending and the pharma’s tactics to extend their exclusivity. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Trelegy Ellipta is approved as a maintenance treatment for COPD and asthma in the US. Image Credit: MAXSHOT.PL / Shutterstock. Singapore’s Health Sciences Authority (HSA) has expanded the label of GlaxoSmithKline (GSK)’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include its use as a maintenance therapy for adults with asthma. The Singapore agency also approved a new dosage strength for the inhaled therapy in asthma. In 2019, HSA approved Trelegy Ellipta as a maintenance therapy for relieving moderate to severe exacerbations in patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is approved as a maintenance treatment for COPD in multiple regions including the US, Europe and China. However, the drug has also been approved for treating asthma in a few countries such as the US. Trelegy Ellipta pulled in £2.2bn ($2.8bn) in global sales for GSK in 2023, as per the company’s financials. The drug sales are expected to rise, with Trelegy Ellipta expected to generate approximately $3.8bn in global sales in 2027, according to a GlobalData analysis. GlobalData is the parent company of Pharmaceutical Technology . Last month, GSK announced plans to cap out-of-pocket costs for eligible patients at $35 per month for its COPD and asthma medications in light of the rising drug prices in the US. Trelegy Ellipta is one of the drugs included in GSK’s programme, which will be implemented across the country no later than 1 January 2025. See Also: UK MHRA approves Advanz Pharma antibiotic for complex infections Japan’s PMDA approves Partner’s inhaled Leukine for aPAP Another therapy looking to target both asthma and COPD populations is Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko). The monoclonal antibody has been approved for treating severe asthma in multiple countries including the US. The companies are evaluating the therapy in patients with moderate to severe COPD in a placebo-controlled Phase II trial (NCT04039113). Data from the trial is expected in H1 this year. Regeneron Pharmaceuticals and Sanofi are also seeking approval for their monoclonal antibody , Dupixent (dupilumab) as a maintenance therapy for COPD. The US Food and Drug Administration (FDA) has set a target action date of 27 June for an approval decision. Dupixent is approved for treating atopic dermatitis , asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.