ATryn: a drug made in goat milk
- The record does not name which of my species, waters, soils or forests were harmed.
ATryn, an antithrombin made in the milk of genetically engineered goats, was approved in the EU in 2006 and in the US in 2009. Its EU marketing authorisation was withdrawn in December 2018 for commercial reasons; it had not been sold since 2015.
EU approval July 2006; US approval 6 February 2009; EU authorisation withdrawn 22 December 2018 for commercial reasons; not sold since 2015 (EMA).
Status As of the latest EMA record in the sources reviewed (22 December 2018): EU marketing authorisation withdrawn for commercial reasons.
What happened
ATryn is a human antithrombin produced in the milk of genetically engineered goats. It was approved in the EU in July 2006. The US Food and Drug Administration approved it on 6 February 2009; Pharmaceutical Technology described it as the first biological product from a genetically engineered animal to receive such approval.
The European Medicines Agency (EMA) lists the EU marketing authorisation as withdrawn on 22 December 2018 for commercial reasons. The EMA records that ATryn had not been sold since 2015.
Further reports on US sales, the partner company and a 2010 takeover of the developer are listed under unverified items.
- 2006July: ATryn approved in the EU
- 20096 February: US FDA approves ATryn
- 2015ATryn no longer sold in the EU (EMA)
- 201822 December: EU marketing authorisation withdrawn for commercial reasons
How it looked
Shown
- Pharmaceutical Technology reported the 2009 approval as the first biological product produced in genetically engineered animals to be approved.Pharmaceutical Technology · Pharmaceutical Technology
Recorded
- The EU marketing authorisation was withdrawn on 22 December 2018 for commercial reasons; the product had not been sold since 2015.
- The US FDA approved ATryn on 6 February 2009.
Who gained
Reached nature or the ground
Gained elsewhere
Responses on record
- European Medicines Agency (2018-12-22): Records the withdrawal of the EU marketing authorisation on 22 December 2018 for commercial reasons, with no sales since 2015. · European Medicines Agency
In court and with insurers
Lawsuits and rulings
Insurers
What nature saw
Nature's report opens this page. Below: further outcomes measured on the ground.
What we don't know
Nature
- Not measured Harm to nature: No independent ecological evaluation is on record.
Court
- None on record No court case on record.
Record
- Insufficient Reported but not independently verified: US sales were only USD 1.5 million cumulatively by July 2010, and the partner Lundbeck withdrew (from a company filing known only through a secondary summary).
- Insufficient Reported but not independently verified: GTC was transferred to the French company LFB in 2010 at about USD 0.30 per share, about USD 21 million in total.
- Insufficient Reported but not independently verified: according to LFB, ATryn left the US market in 2015 because the contract manufacturer doing the purification closed its plant after problems with the FDA.
- None on record The sources reviewed give no sales figure for the EU market.
Did the harm stop?
Not applicable in the sources reviewed: they record a commercial withdrawal, not harm to nature.
Who paid?
Not established in the sources reviewed.
Sources
Company or project
- GTC quarterly report (Form 10-Q)GTC / US Securities and Exchange Commission · 2010
Government and regulators
- ATryn: EPAR (European public assessment report)European Medicines Agency ·
Press and investigations
- First protein produced in transgenic animals approvedPharmaceutical Technology · 2009-02
- BioCentury article on the LFB takeover of GTCBioCentury · 2010-11