PV Bulletin

Orphan Designation Granted for Daratumumab for AL Amyloidosis

Daratumumab has been granted orphan designation by the EMA for the treatment of AL amyloidosis, allowing it market exclusivity and incentives.

Primary source: © 1995 - 2026 European Medicines Agency

PV Impact Brief

Urgency: HighConfidence: high

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.

Action needed

Regulatory requirements for daratumumab will need to be reviewed in light of the orphan designation status granted by the EMA.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Country Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Aug 26, 2026

Full briefing

Practical implication

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.

View original source

  • Source: EMA - What's new
  • Published at source: 2026-08-26T14:19:00.000Z
  • Discovered by monitor: 2026-08-26T22:34:54.943Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signals#Country Requirement#Source-ingestion#Regulator-monitor#European Union#Ema.europa.eu

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