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FDA approves Pfizer’s RSV vaccine, okays Lexicon’s Inpefa as treatment for heart failure
The US Food and Drug Administration (FDA) has approved Pfizer’s RSV vaccine, making it the second vaccine for the viral disease after it approved GSK’s Arexvy last month. The agency has also approved Lexicon Pharmaceuticals’ drug Inpefa (sotagliflozin) for the treatment of heart failure.
The agency has released an updated draft guidance for new anti-diabetic drugs. It is considering new efficacy endpoints for clinical trials of diabetes meds.
The European Medicines Agency (EMA) has recommended revoking the marketing authorization of Novartis’ sickle cell disease drug Adakveo (crizanlizumab).
In regulatory news, FDA has issued a Form 483 with three observations to Shanghai Junshi Biosciences after conducting an inspection at a site that manufactures Coherus Biosciences’ experimental cancer drug. The agency has also issued a Form 483 with three observations to UCB’s manufacturing facility in Braine-l’Alleud (Belgium) after identifying issues with the unit’s control of documents at the facility.
In trial news, Pfizer’s experimental hemophilia therapy – marstacimab – has shown superior results in reducing bleeding rates compared to standard care in a late-stage study. Meanwhile, AstraZeneca’s Imfinzi and Lynparza have shown significant improvements in patients with newly diagnosed advanced or recurrent endometrial cancer in a late-stage trial.
India has started pre-export testing of all cough syrups to avoid incidents that led to deaths of children in The Gambia and Uzbekistan. And Eli Lilly has agreed to pay US$ 13.5 million to settle a long-standing dispute over insulin pricing.
FDA approves Pfizer’s RSV vaccine Abrysvo for older adults
FDA has approved Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults – Abrysvo. The approval comes just weeks after the agency approved GSK’s vaccine Arexvy for the same age group. In a late-stage study, Pfizer’s shot demonstrated 67 percent efficacy among older adults with two or more RSV symptoms and 85.7 percent efficacy against severe illness characterized by three or more symptoms. The vaccine is expected to be available in the third quarter of 2023. Pfizer is also seeking FDA nod for use of Abrysvo to prevent RSV in infants by vaccinating pregnant women.
Approves Lexicon’s Inpefa for heart failure: FDA has granted approval to Lexicon Pharmaceuticals’ drug Inpefa (sotagliflozin) for the treatment of heart failure. Inpefa can be used by adults with heart failure or chronic kidney disease, type 2 diabetes mellitus and other cardiovascular risk factors. Sotagliflozin belongs to a class of medicines that regulates blood glucose levels and reduces the risk of weight gain. It will compete with Eli Lilly’s Jardiance.
EMA to revoke authorization of Novartis’ sickle cell drug due to efficacy concerns
The European Medicines Agency (EMA) has recommended revoking the marketing authorization for Novartis’ sickle cell disease drug Adakveo (crizanlizumab) after determining that the drug’s risks outweigh its benefits. The decision comes after Adakveo failed to demonstrate effectiveness in a phase 3 trial, prompting the agency to re-examine its prior authorization.
FDA releases new draft guidance for diabetes drugs, considers new efficacy endpoint
FDA has released an updated draft guidance to help sponsors demonstrate efficacy for new anti-diabetic drugs and biologics for adults and children with type 1 and type 2 diabetes. The draft guidance replaces a previous version issued in 2008, which was withdrawn in 2020 because its safety recommendations were outdated. The agency said it is considering a reduction in the risk of hypoglycemia, or low blood sugar, to be a clinically relevant outcome measure for these trials alongside a reduction in or maintenance of an acceptable A1C value.
Warns against compounded semaglutide-based drugs: In a rush to meet the growing demand for Novo Nordisk’s popular diabetes and weight loss meds — Ozempic and Wegovy (semaglutide) — some compounding pharmacies are making unauthorized versions of these meds. FDA has warned that compounded versions of these meds may not include the same ingredients as the prescription medications, raising concerns about their safety and effectiveness.
Coherus’ partner site in China gets FDA’s Form 483 for its experimental cancer drug
Coherus BioSciences said FDA has issued a Form 483 with three observations to its partner Shanghai Junshi Biosciences’ manufacturing facility in China during a pre-approval inspection for their experimental cancer drug — toripalimab. Coherus said the observations can be easily addressed. The drugmaker is seeking FDA approval for toripalimab to treat patients with nasopharyngeal carcinoma, a highly aggressive form of head and neck cancer with no approved treatment options in the US.
UCB’s Belgium facility receives FDA’s Form 483 with three observations
FDA has issued a Form 483 with three observations to UCB’s manufacturing facility in Braine-l’Alleud, Belgium. The agency inspected the facility from April 17 to 21, and has identified issues with the quality unit’s control of documents, including ‘uncontrolled’ logs recording cleaning activities in classified areas and shredded documents without the assurance that they didn’t contain quality documents. UCB said all issues highlighted by the FDA have been addressed.
Akebia plans to resubmit anemia drug’s application: In March, FDA had refused to approve Akebia Therapeutics’ drug to treat anemia caused by chronic kidney disease – vadadustat – on safety concerns in non-dialysis patients. Now, the drugmaker said it plans to request a meeting with the FDA and refile its application in the second half of this year.
Pfizer’s hemophilia therapy reduced bleeding rates by 92 percent in late-stage study
Pfizer’s experimental hemophilia therapy – marstacimab – has shown superior results in reducing bleeding rates compared to standard care in a late-stage study. The trial demonstrated a 92 percent reduction in bleeding for severe hemophilia A and B patients without factor VIII or IX antibodies, surpassing factor replacement therapies. Pfizer is conducting another trial with patients who have factor VIII or factor IX antibodies, with results expected in late 2024.
AstraZeneca’s drug combo shows promise in endometrial cancer: AstraZeneca’s blockbuster cancer drugs Imfinzi and Lynparza have shown significant improvements in a late-stage trial in patients with newly diagnosed advanced or recurrent endometrial cancer. When used alongside platinum-based chemotherapy, the drugs improved progression-free survival, meeting one of the primary endpoints of the study.
India begins mandatory pre-export testing of cough syrups
From June 1, the Indian government has made it compulsory for manufacturers of cough syrups to send samples for testing to designated laboratories and obtain a Certificate of Analysis before exporting their products. The Indian health ministry has instructed laboratories to prioritize testing of cough syrup samples. The step comes after toxic substances in cough syrups made by Indian manufacturers were linked to child deaths in The Gambia and Uzbekistan.
Lilly to settle insulin pricing lawsuit: Eli Lilly has agreed to pay US$ 13.5 million to settle a long-standing drug pricing lawsuit. While denying any wrongdoing, Lilly also agreed to continue to cap out-of-pocket insulin costs at US$ 35 per month for eligible users for the next four years.The PharmaCompass Newsletter – Sign Up, Stay Ahead
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