FDA News

FDA grants breakthrough therapy designation to upadacitinib for atopic dermatitis

Michael Severino

The FDA granted breakthrough therapy designation to upadacitinib for the treatment of moderate-to-severe atopic dermatitis in adults who are eligible for systemic therapy, according to the drug’s manufacturer.

Upadacitinib (ABT-494, AbbVie) is an investigational once-daily oral Janus kinase 1-selective inhibitor.

The agency’s decision was supported by positive data from phase 2b study results that were announced in September 2017. Data from the study indicated that 30 mg, 15 mg and 7.5 mg once-daily doses of upadacitinib had greater mean percentage changes in eczema area and severity index score from baseline to 16 weeks, compared with placebo.

Regulatory authorities have not approved upadacitinib and its safety and efficacy have not been validated, according to the release.

“Our history, scientific expertise and leadership in immunology drive our focus to develop new treatment approaches that address urgent and unmet needs,” Michael Severino, MD, executive vice president, research and development and chief scientific officer of AbbVie, said in a press release. “Current treatment options for people living with atopic dermatitis are limited, and addressing these patient needs is important to us. We look forward to advancing upadacitinib into phase 3 studies for atopic dermatitis soon.”

A phase 3 clinical program for the use of upadacitinib to treat atopic dermatitis is expected to start within the first 6 months of 2018.

 

Michael Severino

The FDA granted breakthrough therapy designation to upadacitinib for the treatment of moderate-to-severe atopic dermatitis in adults who are eligible for systemic therapy, according to the drug’s manufacturer.

Upadacitinib (ABT-494, AbbVie) is an investigational once-daily oral Janus kinase 1-selective inhibitor.

The agency’s decision was supported by positive data from phase 2b study results that were announced in September 2017. Data from the study indicated that 30 mg, 15 mg and 7.5 mg once-daily doses of upadacitinib had greater mean percentage changes in eczema area and severity index score from baseline to 16 weeks, compared with placebo.

Regulatory authorities have not approved upadacitinib and its safety and efficacy have not been validated, according to the release.

“Our history, scientific expertise and leadership in immunology drive our focus to develop new treatment approaches that address urgent and unmet needs,” Michael Severino, MD, executive vice president, research and development and chief scientific officer of AbbVie, said in a press release. “Current treatment options for people living with atopic dermatitis are limited, and addressing these patient needs is important to us. We look forward to advancing upadacitinib into phase 3 studies for atopic dermatitis soon.”

A phase 3 clinical program for the use of upadacitinib to treat atopic dermatitis is expected to start within the first 6 months of 2018.