- The European Commission (EC) granted orphan drug designation to Panbela Therapeutics' ( NASDAQ: PBLA ) ivospemin to treat a type of pancreatic cancer.
- The EC adopted the positive opinion issued by a panel of the European Medicines Agency (EMA) to designate the status to ivospemin (SBP-101) in combination with gemcitabine and nab-Paclitaxel to treat patients with metastatic pancreatic ductal adenocarcinoma (PDA).
- "The designation of orphan drug status within the EU is an important achievement as we continue to advance the global ASPIRE trial with the potential that this may be an option for patients with first line metastatic pancreatic cancer in the future," said Panbela President and CEO Jennifer Simpson.
- The orphan drug designation in the EU is aimed at therapies for treating or preventing diseases which affect fewer than five in 10,000 people in the EU. The designation provides certain incentives, including 10 years of market exclusivity for the drug, if approved.
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Panbela's therapy for pancreatic cancer gets orphan drug status in EU