EMA Makes Orphan Drug Recommendations - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

EMA Makes Orphan Drug Recommendations


ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP’s recommendations were four designation applications for rare forms of lipodystrophy.

The COMP meeting also confirmed Vertex Pharmaceuticals's Kalydeco (ivacaftor) for orphan designation. The confirmation follows the recommendation made by EMA’s Committee for Medicinal Products for Human Use (CHMP). Based on CHMP requirements, COMP confirmed that “Kalydeco continues to fulfill the orphan designation criteria.” COMP will publish the review of Kalydeco’s orphan designation after the European public assessment report for the drug is published.

COMP’s recommendations will be sent to the European Commission for adoption. Sponsors will have access to certain incentives during development once the orphan designation is granted.

A full list of COMP’s recommendations can be found in COMP’s monthly report.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What is the single greatest threat to maintaining manufacturing processes at your facility?
Quality issues
Facility/environment problems
Process development problems
Production equipment downtime
Raw material supply problems
Regulatory restrictions
Business decisions to limit production
Quality issues
100%
Facility/environment problems
0%
Process development problems
0%
Production equipment downtime
0%
Raw material supply problems
0%
Regulatory restrictions
0%
Business decisions to limit production
0%
View Results
UPCOMING CONFERENCES

Programs for Investigational and Pre-Launch Drugs
Philadelphia, PA
July 17-18, 2013
Request Brochure

Strategic Pipeline Planning & Portfolio Valuation
Philadelphia, PA
August 13-14, 2013
Request Brochure

MES 2013 - Forum on Manufacturing Execution Systems
Philadelphia, PA
August 14-15, 2013
Request Brochure

Mobile Innovation for the Life Sciences Industry
Philadelphia, PA
August 20-21, 2013
Request Brochure

See All Conferences >>

Eric Langer Outsourcing Outlook Eric LangerOutsourcing's Modest Role as a Cost-Containment Strategy
Patricia Van Arnum Ingredients Insider Patricia Van ArnumIntellectual Property Battles in Solid-State Chemistry
Nathan Jessop Industry Insider Nathan Jessop Campaign Against Counterfeit Drugs Continues
Lynn Torbeck Statistical Solutions Lynn D. TorbeckCompositing Samples and the Risk to Product Quality
 More
Praise and Perils for Biotechnology Patent Policy
Risk-Mitigation Strategies in Drug Manufacturing for Emerging Markets
Quality Focus: Ensuring Raw Material Transparency
Advertising of Prescription Drugs  Keeping it Honest and Balanced
Key Ways for Ensuring Global Regulatory Compliance
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here