AbbVie Inc (NYSE:ABBV) has submitted a supplemental application to the FDA for Imbruvica (ibrutinib) for chronic graft versus host disease (cGVHD).
- The application covers Imbruvica for pediatric and adolescent patients one year and older with cGVHD after the failure of one or more lines of systemic therapy.
- A New Drug Application (NDA) was also submitted for an oral suspension formulation of Imbruvica to provide an alternative administration option for pediatric patients.
- If approved, this represents AbbVie's first pediatric indication for Imbruvica.
- Also See: AbbVie Expects Solid FY22 As Botox, Skyrizi Power Q4 Earnings.
- The iMAGINE trial enrolled 59 patients 1-19 years with relapsed/refractory (R/R) or new-onset moderate/severe cGVHD. Results showed an overall response rate of 78% with Imbruvica.
- After 20 weeks, sustained response rates were observed in 70% and 58% of treatment-naive and R/R responders, respectively.
- In 2017, Imbruvica was first approved as a single-agent therapy for adult patients with cGVHD who have experienced failure of prior systemic treatment, becoming the first FDA-approved treatment for adults with cGVHD.
- Imbruvica could be the first FDA-approved BTKi treatment option for pediatric and adolescent patients with cGVHD.
- Price Action: ABBV shares are down 1.83% at $146.75 during the market session on the last check Monday.
