FDA grants ‘Breakthrough Therapy Designation’ for upadacitinib for atopic dermatitis

 

The Food and Drug Administration has granted “Breakthrough Therapy Designation” for the investigational, once-daily oral Janus kinase 1 (JAK1)-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.

The Breakthrough Therapy Designation is based on positive phase 2b results announced in Sept. 2017. The study found that patients treated with upadacitinib achieved statistically significant improvements in the primary endpoint (greater mean percentage change from baseline in Eczema Area and Severity Index score) and in all skin- and itch-specific secondary endpoints across all doses (30 mg, 15mg, or 7.5 mg once-daily) at week 16, compared with placebo (P less than .05). Reduction in itch was observed within the first week and improvement in skin within the first 2 weeks (P less than .001 across all doses). Of patients receiving the 30 mg once-daily dose of upadacitinib, 50% had clear or almost clear skin, according to a press release. There were 42 patients in each of the three treatment groups and 41 patients in the placebo group in this randomized, double-blind, parallel-group study sponsored by AbbVie, which discovered and developed upadacitinib.

Currently, upadacitinib is not approved by regulatory authorities, and its safety and efficacy have not been established. The FDA states that inclusion in the Breakthrough Therapy Designation program means that a drug is intended to be “used alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition” and “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”

The phase 3 clinical program is expected to begin in the first half of 2018, according to AbbVie. Any additional information on the clinical trials for upadacitinib is available at clinicaltrials.gov.

llaubach@frontlinemedcom.com

SOURCE: Prnewswire.com.

 

The Food and Drug Administration has granted “Breakthrough Therapy Designation” for the investigational, once-daily oral Janus kinase 1 (JAK1)-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.

The Breakthrough Therapy Designation is based on positive phase 2b results announced in Sept. 2017. The study found that patients treated with upadacitinib achieved statistically significant improvements in the primary endpoint (greater mean percentage change from baseline in Eczema Area and Severity Index score) and in all skin- and itch-specific secondary endpoints across all doses (30 mg, 15mg, or 7.5 mg once-daily) at week 16, compared with placebo (P less than .05). Reduction in itch was observed within the first week and improvement in skin within the first 2 weeks (P less than .001 across all doses). Of patients receiving the 30 mg once-daily dose of upadacitinib, 50% had clear or almost clear skin, according to a press release. There were 42 patients in each of the three treatment groups and 41 patients in the placebo group in this randomized, double-blind, parallel-group study sponsored by AbbVie, which discovered and developed upadacitinib.

Currently, upadacitinib is not approved by regulatory authorities, and its safety and efficacy have not been established. The FDA states that inclusion in the Breakthrough Therapy Designation program means that a drug is intended to be “used alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition” and “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”

The phase 3 clinical program is expected to begin in the first half of 2018, according to AbbVie. Any additional information on the clinical trials for upadacitinib is available at clinicaltrials.gov.

llaubach@frontlinemedcom.com

SOURCE: Prnewswire.com.

 

The Food and Drug Administration has granted “Breakthrough Therapy Designation” for the investigational, once-daily oral Janus kinase 1 (JAK1)-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.

The Breakthrough Therapy Designation is based on positive phase 2b results announced in Sept. 2017. The study found that patients treated with upadacitinib achieved statistically significant improvements in the primary endpoint (greater mean percentage change from baseline in Eczema Area and Severity Index score) and in all skin- and itch-specific secondary endpoints across all doses (30 mg, 15mg, or 7.5 mg once-daily) at week 16, compared with placebo (P less than .05). Reduction in itch was observed within the first week and improvement in skin within the first 2 weeks (P less than .001 across all doses). Of patients receiving the 30 mg once-daily dose of upadacitinib, 50% had clear or almost clear skin, according to a press release. There were 42 patients in each of the three treatment groups and 41 patients in the placebo group in this randomized, double-blind, parallel-group study sponsored by AbbVie, which discovered and developed upadacitinib.

Currently, upadacitinib is not approved by regulatory authorities, and its safety and efficacy have not been established. The FDA states that inclusion in the Breakthrough Therapy Designation program means that a drug is intended to be “used alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition” and “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”

The phase 3 clinical program is expected to begin in the first half of 2018, according to AbbVie. Any additional information on the clinical trials for upadacitinib is available at clinicaltrials.gov.

llaubach@frontlinemedcom.com

SOURCE: Prnewswire.com.