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Astra’s Farxiga bags FDA nod for heart failure; post cough syrup deaths, FDA issues guidance on contaminants
AstraZeneca’s blockbuster drug Farxiga (dapagliflozin) received an extended approval from the US Food and Drug Administration (FDA) to treat heart failure patients. The agency has also approved Otsuka Pharmaceutical’s Rexulti (brexpiprazole) to treat agitation in Alzheimer’s patients, making it the first drug for the indication.
Gilead has won a lawsuit against the US government over the infringement of patents for its pre-exposure prophylaxis (PrEP) drugs for HIV infection.
Post the cough syrup deaths, FDA has issued a new, 11-page guidance for manufacturers to conduct rigorous testing for two toxic contaminants – diethylene glycol (DEG) and ethylene glycol (EG) – in drugs and dietary supplements.
In regulatory news, FDA has rejected Novo Nordisk’s experimental drug candidate concizumab as a treatment for hemophilia A and B patients. And Sun Pharma has recalled over 24,000 prefilled syringes of Fyremadel (ganirelix acetate) injection in the US due to the presence of particulate matter.
In deals, Baxter International is selling its CDMO BioPharma Solutions to private equity groups Warburg Pincus and Advent International for US$ 4.25 billion. Sobi is buying CTI BioPharma for US$ 1.7 billion, and Bayer has bought rights to work with Bicycle Therapeutics on the latter’s radiotherapy cancer drug candidates.
Astra’s Farxiga receives extended FDA approval to treat heart failure patients
AstraZeneca’s blockbuster oral diabetes drug Farxiga (dapagliflozin) has received an add-on approval from FDA to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits in adults with heart failure.
The approval was based on data from a phase 3 trial that reduced the risk of hospitalization and death from a cardiovascular event by 18 percent in patients with mildly reduced or preserved ejection fraction. The extended approval puts Farxiga on a par with Eli Lilly and Boehringer Ingelheim’s Jardiance, which was approved to treat a wide range of heart failure patients last year.
Otsuka’s Rexulti becomes first FDA-approved med to treat agitation in Alzheimer’s
Otsuka Pharmaceutical’s Rexulti (brexpiprazole) has bagged approval from the FDA to treat agitation in Alzheimer’s patients, making it the first drug for the indication. The approval is based on two late-stage studies that showed Rexulti significantly improved agitation in Alzheimer’s patients compared to a placebo. Rexulti, which has been jointly developed by Otsuka and Lundbeck, is already approved in the US to treat major depressive disorder and schizophrenia.
Fabry disease treatment gets EU nod: Protalix BioTherapeutics and Chiesi Farmaceutici’s enzyme replacement therapy PRX-102 (pegunigalsidase alfa) has received marketing authorization in the EU as a treatment for adults with Fabry disease, a rare genetic disorder. The authorization makes PRX-102 the first pegylated enzyme for adult patients suffering from the disease.
Meanwhile, the European Medicines Agency (EMA) has authorized Gilead’s Hepcludex (bulevirtide) as a treatment for patients with hepatitis delta virus (HDV) and compensated liver disease. The FDA had rejected the drug’s approval a few months ago, citing manufacturing and delivery concerns.
Post cough syrup deaths, FDA issues guidance for testing toxic contaminants
FDA has issued a new, 11-page guidance for manufacturers to conduct rigorous testing for two harmful chemical contaminants – diethylene glycol (DEG) and ethylene glycol (EG) – in pharmaceuticals and dietary supplements. The guidance recommends testing for DEG and EG at risk-based limits and provides analytical methods for detecting these contaminants. Over the last year, DEG and EG have led to a spate of child deaths in The Gambia, Uzbekistan and Indonesia.
Gilead wins lawsuit against US government over infringement of HIV drug patents
Gilead Sciences has won a lawsuit against the US government, with a federal jury ruling that the drugmaker did not infringe on the government’s patents with its regimen of Truvada and Descovy as pre-exposure prophylaxis (PrEP) to prevent HIV infection. The jury also ruled that the government’s patents were invalid. The government had sued Gilead for over US$ 1 billion, alleging that the drugmaker had failed to compensate it for discovering the PrEP properties of the drugs.
Shkreli’s company files for bankruptcy: Vyera Pharmaceuticals, a company founded by ‘Pharma Bro’ Martin Shkreli, has filed for Chapter 11 bankruptcy in Delaware. The bankruptcy has been attributed to declining profits, increased competition for generic drugs, and litigation alleging that Vyera suppressed competition for its most valuable drug, Daraprim.
FDA panel paves way for Perrigo’s Opill to become first OTC birth control pill in US
An external panel of advisers to FDA has voted 17 to 0 in favor of allowing sales of Perrigo’s contraceptive drug without a prescription. If approved, Opill will become America’s first over-the-counter (OTC) non-estrogen contraceptive pill. Earlier, FDA reviewers had expressed concerns about Opill being approved for OTC sale, claiming it would lead to inappropriate usage.
FDA rejects Novo’s hemophilia treatment:FDA has rejected Novo Nordisk’s experimental drug candidate concizumab as a treatment for hemophilia A and B patients. In its complete response letter (CRL), the agency has asked Novo to furnish more information related to the monitoring and dosing of patients as well as the manufacturing process to ensure that the drug is administered as intended.
Sun Pharma recalls infertility drug in US: Sun Pharma has recalled over 24,000 prefilled syringes of Fyremadel (ganirelix acetate) injection in the US due to the presence of particulate matter. FDA said the Indian drugmaker initiated the recall after a piece of glass was found in a prefilled syringe meant to treat infertility in women. Sun Pharma’s New Jersey-based unit has also recalled 16,450 vials of norepinephrine bitartrate injection due to failed impurities and degradation specifications.
Baxter sells CDMO unit to PE firms for US$ 4.25 bn; Sobi snaps up CTI BioPharma
Device maker Baxter International is selling its CDMO BioPharma Solutions to private equity groups Warburg Pincus and Advent International for US$ 4.25 billion in cash. The sale will enable Baxter to pay off part of the debt it incurred when it bought medical device maker Hill-Rom Holdings for US$ 10.5 billion in 2021. The deal is expected to close later this year.
Sobi buys CTI BioPharma: Swedish blood disorder specialist Sobi has bought Seattle-based CTI BioPharma for US$1.7 billion. The primary asset Sobi has gained through this buyout is JAK2 inhibitor Vonjo (pacritinib), an oral drug that bagged FDA’s accelerated approval last year as the first treatment for cytopenic myelofibrosis, a type of bone marrow cancer.
Bayer, Bicycle alliance: Bayer has acquired the rights to work with Bicycle Therapeutics on the latter’s radiotherapy cancer drug candidates. Under the deal, Bicycle stands to receive an upfront payment of US$ 45 million and potentially up to US$ 1.7 billion in milestone payments, along with tiered royalties on sales.The PharmaCompass Newsletter – Sign Up, Stay Ahead
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