Date: 2017-04-24
Type of information: Granting of a Market Authorisation in the US
Product name: Thymoglobulin®
Compound: anti-thymocyte globulin (rabbit)
Therapeutic area: Transplantation
Action mechanism: polyclonal antibody
Company: Sanofi (France)
Disease: prevention of acute rejection in patients receiving a kidney transplant
Latest news: • On April 24, 2017, Sanofi announced that the FDA approved Thymoglobulin® [anti-thymocyte globulin (rabbit)], for use in conjunction with concomitant immunosuppression in the prophylaxis, or prevention, of acute rejection in patients receiving a kidney transplant. The FDA approval was based on two randomized multicenter studies comparing Thymoglobulin to interleukin-2 receptor antagonists (IL2RA: basiliximab or daclizumab) in deceased donor kidney transplant recipients. The first study in kidney transplant patients (n=278) at increased risk of acute rejection or delayed graft function showed a significantly lower incidence of the treatment failure as measured by a composite endpoint (biopsy-proven acute rejection, graft loss, death or lost to follow-up) within 12 months following transplantation in the Thymoglobulin group compared to patients in the basiliximab group (25 percent versus 38 percent; p=0.02). The second study was an investigator-sponsored study in kidney transplant patients (n=230) at high immunological risk of rejection. Patients received either Thymoglobulin or daclizumab and also showed a lower incidence of treatment failure as measured by the composite endpoint 12 months following transplantation (25 percent versus 34 percent). The estimated between-treatment group difference (Thymoglobulin to daclizumab) was -9% (95% CI, -19.9% to 3.6%) demonstrating non-inferiority of Thymoglobulin compared with daclizumab. The pooled analysis of both studies (n=508) showed a composite endpoint rate within 12 months post transplantation of 25.1 percent in the Thymoglobulin group compared with 36.0 percent in the IL2RA group. The estimated between-treatment group difference (Thymoglobulin to IL2RA) was -10.9% (95% CI, -18.8% to - 2.9%), which demonstrates superiority of Thymoglobulin for the prevention of acute rejection. The most frequent adverse reactions seen in these clinical trials (more than 25% of patients receiving Thymoglobulin) include: leukopenia, hyperkalemia, urinary tract infection and pyrexia. Thymoglobulin was originally approved by US regulatory authorities in 1998 for the treatment of renal transplant acute rejection. Thymoglobulin is marketed by Sanofi Genzyme, the specialty care global business unit of Sanofi.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-04-24
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
