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Pharmaceutical industry

FDA Grants Orphan Drug Status to AstraZeneca's MERREM I.V. for Treating Life-threatening Lung Infections in CF Patients

Strategic Insights

— 1 min read

The U.S. Food and Drug Administration (FDA) has granted AstraZeneca orphan drug status for its anti-infective medicine, MERREM I.V. (meropenem for injection), specifically for the management of acute pulmonary exacerbations in Cystic Fibrosis (CF) patients with chronic lower respiratory tract infections. This move enables AstraZeneca to continue researching new indications for MERREM I.V., addressing a critical need for patients with CF, a rare genetic disease affecting 30,000 children and adults in the United States. Cystic Fibrosis patients regularly suffer from severe lung infections, obstructed breathing, and diabetes, complicating their lives significantly.

Key Takeaways:

  • The FDA has granted AstraZeneca orphan drug status for MERREM I.V. to develop new indications for managing acute pulmonary exacerbations in Cystic Fibrosis patients.
  • Cystic Fibrosis is a rare genetic disease affecting 30,000 children and adults in the United States, with millions of people being symptomless carriers of the CF gene.
  • MERREM I.V. is indicated in the U.S. as single agent therapy for the treatment of intra-abdominal infections in adults and children, and bacterial meningitis in children three months of age and older.
  • Lung infections, obstructed breathing, and diabetes are common complications of Cystic Fibrosis, a genetic disease with no cure.
  • AstraZeneca is committed to enhancing its research with MERREM I.V. to help thousands of CF sufferers worldwide who regularly experience severe lung infections.
  • The FDA's orphan drug designation will allow AstraZeneca to continue researching new indications for MERREM I.V. in managing life-threatening lung infections in CF patients.
  • Ronald Krall, M.D., Senior Vice President of Clinical Development and Medical Affairs at AstraZeneca, thanked the FDA for its support in exploring treatments for rare diseases.

Statistics:

  • 30,000 children and adults in the United States are affected by Cystic Fibrosis (1).
  • Approximately 25% of children born with Cystic Fibrosis will have a reduced life expectancy (2).
  • 1 in 31 Americans is an unknowing, symptomless carrier of the CF gene (3).
  • MERREM I.V. is contraindicated in patients with known hypersensitivity to any component of the product or to other drugs in the same class, or in patients who have demonstrated anaphylactic reactions to beta-lactams (1).

Sources:

  • (1) Hope for CF Patients At Risk for Developing Life-threatening Lung Infections. Business Wire. May 15, 2000.
  • (2) Facts about Cystic Fibrosis. National Institute of Health.
  • (3) Facts about Cystic Fibrosis. Cystic Fibrosis Foundation.

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