Date: 2018-01-04
Type of information: Granting of the Breakthrough Therapy status
Product name: maribavir (SHP620)
Compound: maribavir
Therapeutic area: Infectious diseases
Action mechanism:
- antiviral agent. Maribavir is a member of a new class of drugs called benzimidazole ribosides. By inhibiting the CMV UL97 protein kinase, maribavir potentially affects several critical processes in CMV replication including viral DNA synthesis, viral gene expression, encapsidation and egress of mature capsids from the nucleus. Further research to confirm these findings will be conducted in pending Phase 3 studies.
Company: Viropharma (USA), now Shire (UK - USA)
Disease:
- cytomegalovirus (CMV) disease in patients with impaired cell mediated immunity
- cytomegalovirus infection and disease in transplant patients resistant or refractory to prior therapy
Latest news:
- • On January 4, 2018, Shire announced that the FDA has granted Breakthrough Therapy Designation for maribavir (SHP620), a Phase 3 investigational treatment for cytomegalovirus (CMV) infection and disease in transplant patients resistant or refractory to prior therapy.
- Breakthrough Therapy Designation status for maribavir was granted based on the data from two Phase 2 studies, including a Phase 2 trial in 120 patients ages 12 or older with CMV infection. In the study, 67% of patients treated with varying doses of maribavir (400 to 1200 mg twice daily) for up to 24 weeks had no detectable levels of the virus in their blood plasma within six weeks of starting treatment. Dysgeusia (taste disturbance) was the most commonly reported treatment-emergent adverse event (AE) considered to be related to maribavir. Other related treatment-emergent AEs occurring in greater than or equal to 5% of study participants for any dose included nausea, CMV infection, immunosuppressant drug level increased, diarrhea, rash, vomiting, anaemia, and pruritus (itch).
- • On January 4, 2018, Shire announced that the FDA has granted Breakthrough Therapy Designation for maribavir (SHP620), a Phase 3 investigational treatment for cytomegalovirus (CMV) infection and disease in transplant patients resistant or refractory to prior therapy. Breakthrough Therapy Designation status for maribavir was granted based on the data from two Phase 2 studies, including a Phase 2 trial in 120 patients ages 12 or older with CMV infection. In the study, 67% of patients treated with varying doses of maribavir (400 to 1200 mg twice daily) for up to 24 weeks had no detectable levels of the virus in their blood plasma within six weeks of starting treatment.
- • On June 11, 2013, ViroPharma has announced that the European Commission has granted orphan drug designation for maribavir for treatment of cytomegaloviral (CMV) disease in patients with impaired cell mediated immunity. ViroPharma is currently conducting two Phase 2 dose ranging studies of oral maribavir at one of three doses (400mg, 800mg or 1200mg BID) in transplant recipients. The first is a randomized, active (valganciclovir) controlled maribavir dose blinded multicenter Phase 2 study in up to 160 European hematopoietic stem cell or solid organ transplant recipients who have demonstrated CMV viremia but do not have CMV organ disease. ViroPharma is also conducting a randomized, dose blinded multicenter Phase 2 study intended to enroll up to 120 hematopoietic stem cell or solid organ transplant recipients who have resistant or refractory CMV viremia with or without CMV organ disease. This study is currently being conducted in the US with plans to extend to include European sites.
- • On 16-17 april 2013, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for maribavir for treatment of cytomegalovirus disease in patients with impaired cell mediated immunity.
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:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2011-05-
Orphan status UE: 2013-06-07
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
