FDA grants orphan designation for ABTL0812 in Pancreatic Cancer

US Food and Drug Administration (FDA) has awarded ABTL0812, a leading candidate of Ability Pharmaceuticals.

Release Date: 21-Jan-2017



US Food and Drug Administration (FDA) has awarded ABTL0812, a leading candidate of Ability Pharmaceuticals, with orphan drug designation for the treatment of patients with pancreatic cancer. Previously the drug has been designated as orphan drug for treatment of pediatric cancer neuroblastoma by European medicines Agency (EMA) and FDA in 2015.

 

In preclinical studies, ABTL0812 has shown the ability in pancreatic cancer as single agent and synergistic effect (by 8 to 90 times) in an arrangement with taxanes, platinum compounds and gemcitabine, with induction of tumor regression without encouraging the toxicity associated with chemotherapy. First line therapy in patients with either locally advanced or metastatic pancreatic cancer includes these compounds, and administered in combination with ABTL0812 has the potential to greatly improve the treatment outcome.

 

The FDA's designation of Orphan Status is granted to provide ultimate solutions for the patient suffering from life threatening diseases and to promote the developed therapies or drugs for rare diseases and disorders. Orphan Status can be applied to products proven safe and effective in treating conditions that affect a relatively small number of patients, and the designation may entitle up to seven years of US marketing exclusivity upon regulatory approval. Companies whose drugs have an orphan designation also receive certain tax credits and are exempted from paying prescription drug user fees normally required of companies submitting products for approval.

 

For Orphan Drug Clinical Insight Reports Contact:  neeraj@kuickresearch.com

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