4
ALL2
Amgen Inc1
CSL1
F. Hoffmann-La RocheYear
4
ALL1
20213
2020DEALS // DEV.
4
ALL4
DevelopmentsCountry
4
ALL1
AUSTRALIA1
SWITZERLAND2
U.S.A4
ALL1
Amgen Inc3
InapplicableTherapeutic Area
4
ALL3
Immunology1
Rare Diseases and DisordersStudy Phase
4
ALL4
Approved FDFDeal Type
4
ALL4
InapplicableProduct Type
4
ALL1
Antibody3
Other Small MoleculeDosage Form
4
ALL3
Oral Capsule1
Subcutaneous InjectionLead Product
4
ALL3
Avacopan1
AzathioprineTarget
4
ALL3
C5a receptor1
IL-6-alpha receptorLead Product(s) : Satralizumab,Azathioprine,Mycophenolate Mofetil
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Roche’s Enspryng Leads Latest CHMP Recommendations
Details : Leading those recommendations is Roche’s Enspryng (satralizumab), which received a positive opinion for the treatment of the rare autoimmune disease neuromyelitis optica spectrum disorders (NMOSD).
Product Name : Enspryng
Product Type : Antibody
Upfront Cash : Inapplicable
April 23, 2021
Lead Product(s) : Satralizumab,Azathioprine,Mycophenolate Mofetil
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Avacopan,Azathioprine,Rituximab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The NDA included data from the global, Phase III ADVOCATE trial, which demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group.
Product Name : Tavneos
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 17, 2020
Lead Product(s) : Avacopan,Azathioprine,Rituximab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Avacopan,Azathioprine,Rituximab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The study showed that avacopan was as effective as prednisone therapy in bringing patients into remission by 26 weeks, and superior to prednisone for sustained remission after 52 weeks.
Product Name : Tavneos
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 11, 2020
Lead Product(s) : Avacopan,Azathioprine,Rituximab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Avacopan,Azathioprine,Rituximab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Amgen Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : If approved, avacopan would be the first orally administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis.
Product Name : Tavneos
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 11, 2020
Lead Product(s) : Avacopan,Azathioprine,Rituximab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Amgen Inc
Deal Size : Inapplicable
Deal Type : Inapplicable