Date: 2011-12-20
Type of information: Withdrawal of a market application in the EU
Product name: Tesamorelin FERRER
Compound: tesamorelin
Therapeutic area: Infectious diseases
Action mechanism: analogue of the growth hormone-releasing factor (GH-RH)
Company: Theratechnologies (Canada) Ferrer Internacional (Spain)
Disease: treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy
Latest news: * On June 22, 2012, Theratechnologies has announced that the company has been informed by Ferrer Internacional, its commercial partner responsible for all regulatory filings in Europe, that it is withdrawing the MAA filed with the EMA for tesamorelin for the treatment of excess abdominal fat in HIV infected patients with lipodystrophy.
Ferrer’s decision to withdraw the MAA follows an oral explanation with the EMA’s Committee for Medicinal Products for Human Use (CHMP). As higher IGF-1 (Insulinlike growth factor 1) levels were identified as a potential safety concern for long-term use of tesamorelin, the CHMP indicated that the lack of data on cardiovascular risk markers did not allow the committee to conclude on a positive benefit/risk balance.
As a result of the withdrawal of the MAA in the European Union, Theratechnologies is revising its guidance and no longer expects to be EBITDA positive in 2013. Further guidance will not be provided at this time.Theratechnologies has announced that its partner, Ferrer Internacional S.A. has filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for tesamorelin, an analogue of the growth hormone-releasing factor (GRF), proposed for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy.
* On June 27, 2011, the MAA submitted by Ferrer has been accepted by the EMA. Under a distribution and licensing agreement between the two companies, Ferrer holds the commercialization rights to tesamorelin for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy in Europe and is responsible for conducting all related regulatory and commercialization activities. The MAA, submitted under the name "Tesamorelin FERRER", is based on the positive results from two Phase 3 clinical trials, which enrolled more than 800 patients, and follows a marketing approval by the FDA received in November 2010. In the U.S., tesamorelin is marketed under the trade name Egrifta®.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE: 2011-06-06
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE: 2012-06-22
US authorization: November 2010 (brand name : Egrifta®)
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
