Axanum and expanded nexium indication rejected by fda


Axanum and expanded nexium indication rejected by fda

The Food and Drug Administration (FDA), USA has denied approval of AstraZeneca's Axanum (aspirin plus esomeprazole magnesium) and an expanded indication for AstraZeneca's Nexium (esomeprazole magnesium). AstraZeneca received a CRL (Complete Response Letter) for the new drug application for Axanum tablets, as well as a CRL for the supplemental new drug application (sNDA) for Nexium.

In a press release, AstraZeneca says it is evaluating the CRLs and will continue discussions with the FDA to decide on the next steps for the two medications. The company said it will respond to the FDA's request for additional information.

Both applications were submitted by AstraZeneca to the FDA on April 30th, 2009, seeking approval for:

  • Axanum - for the risk reduction of low dose ASA-associated gastric and/or duodenal ulcers in patients at risk.
  • Nexium - the supplemental new drug application was submitted for the risk reduction of low-dose aspirin-associated peptic ulcers.
This is a setback for AstraZeneca's attempt to extend the life of Nexium, its blockbuster acid reflex medication, through new uses. Nexium faces the loss of patent protection in major markets.

About AxanumTM

Axanum is a fixed-dose combination containing low-dose ASA (acetylsalicylic acid) and the active ingredient of the PPI Nexium® (esomeprazole, formulated as enteric coated pellets) developed by AstraZeneca for the prevention of cardio- and cerebrovascular (CV) events in patients requiring continuous low-dose ASA treatment, and at risk for developing ASA associated gastric and/or duodenal ulcers.

Possible fracture risk with high dose long-term use of proton pump inhibitors

Proton pump inhibitors, available by prescription and over-the-counter (OTC), reduce the amount of acid in the stomach. Prescription proton pump inhibitors include:
  • esomeprazole (Nexium)
  • dexlansoprazole (Dexilant)
  • omeprazole (Prilosec, Zegerid)
  • lansoprazole (Prevacid)
  • pantoprazole (Protonix)
  • rabeprazole (Aciphex)
Prescription proton pump inhibitors are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and esophagus inflammation.

OTC versions, used for the treatment of frequent heartburn, include omeprazole (Prilosec OTC, Zegerid OTC) and lansoprazole (Prevacid 24HR).

Joyce Korvick, M.D., deputy director for safety in FDA's Division of Gastroenterology Products, said:

Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses. Because these products are used by a great number of people, it's important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.

FDA's warning and decision to revise the labeling of proton pump inhibitors are based on its review of several epidemiological studies that reported an elevated risk of fractures of the hip, wrist and spine in patients using proton pump inhibitors. Both the Warnings and Precautions section of the prescription labeling and the Drug Facts label on OTC proton pump inhibitors will address these findings.

Doctors and patients should weigh the known benefits against the potential risks of proton pump inhibitors when deciding whether these drugs are suitable for treatment. Patients should also talk with their health care professional about any concerns.

Sources: FDA, AstraZeneca

30. Esomeprazole as an Example of Drug Testing and Usage (Video Medical And Professional 2020).

Section Issues On Medicine: Disease