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Daratumumab was granted orphan designation on 25 May 2018, recognizing it for the treatment of AL amyloidosis, qualifying it for specific regulatory benefits.
The orphan designation allows daratumumab to be marketed without competition for a certain period, incentivizing its development for a rare and life-threatening condition, consequently enhancing treatment options for patients.
Regulatory requirements for daratumumab will need to be reviewed in light of the orphan designation status granted by the EMA.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Regulatory requirements for daratumumab will need to be reviewed in light of the orphan designation status granted by the EMA.
The European Medicines Agency (EMA) has granted orphan designation (EU/3/18/2020) to daratumumab for the treatment of AL amyloidosis, a serious and rare condition affecting approximately 52,000 people in the EU. This designation provides incentives such as marketing exclusivity to support the development of treatments for rare diseases.
What changed: Daratumumab was granted orphan designation on 25 May 2018, recognizing it for the treatment of AL amyloidosis, qualifying it for specific regulatory benefits.
Why it matters: The orphan designation allows daratumumab to be marketed without competition for a certain period, incentivizing its development for a rare and life-threatening condition, consequently enhancing treatment options for patients.
Practical implication: Regulatory requirements for daratumumab will need to be reviewed in light of the orphan designation status granted by the EMA.
Published from the regulator source ingestion pipeline after PV impact triage.
Review and verify that any cosmetic products sourced or distributed comply with the manufacturers listed in the updated QUEST system.
Annual reviews of new information will be conducted to update the summary, requiring continuous monitoring and data submission in response to findings.
Marketing authorization holders (MAHs) must review and potentially update their product labeling to align with the new regulations by 11 April 2029 for products authorized before 11 May 2024.
Regulatory Intelligence leads should initiate monitoring of feedback and prepare for potential regulatory adjustments related to the specified substances.
