Eli Lilly Gets FDA Breakthrough Status for Alopecia Drug
By Ruchi Jhonsa, Ph.D.
Edited By Rajaneesh K. Gopinath, Ph.D.
Eli Lilly & Company and Incyte Corporation today announced that they have received the FDA’s breakthrough therapy designation for Baricitinib, a JAK kinase inhibitor for the treatment of alopecia areata, an autoimmune disorder that causes hair loss on the scalp, face and other areas of the body. The drug will prevent the immune system from attacking hair follicles, thereby restoring normal hair growth. If approved, this drug will be the first FDA authorized treatment for alopecia areata (AA).
“Patients with AA currently do not have any FDA-approved treatment options available to them,” said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. “AA not only causes hair loss but also may be a psychosocial burden for people living with this disease. At Lilly, we aspire to create new medicines that can give hope to patients. We look forward to working with the FDA to further explore Barticinib’s potential to become the first approved treatment option for these individuals.
Baricitinib has already received approval for treating active to severe active rheumatoid arthritis under the name OLUMIANT in patients who have previously been unresponsive to other TNF inhibitor therapies. The drug’s success in treating rheumatoid arthritis stems from its skyrocketing sales record in over 65 countries, including the US, member states of the EU and Japan.
Baricitinib: Mode of Action
Similar to rheumatoid arthritis, AA is mainly driven by cytotoxic T lymphocytes that release JAK dependent cytokines responsible for several inflammatory and autoimmune diseases. However, the condition can be reversed if the JAK/STAT pathway is inhibited. Based on this knowledge, a few drugs have been developed that selectively or broadly inhibit four JAK enzymes. Baricitinib is one of the JAK kinase inhibitors that inhibit three of those four. In late 2009, Eli Lilly signed an exclusive worldwide license and collaboration agreement with Incyte for commercializing Baricitinib and other compounds for inflammatory and autoimmune diseases.
The Decisive Trial that Fetched Breakthrough Status
The breakthrough designation was granted following strong preliminary results in the Phase 2/3 study, BRAVE-AA1, which evaluated the safety of Baricitinib versus placebo in adult patients with AA. Two drug doses of 2 mg and 4 mg are currently being assessed for efficacy and safety. At 36 weeks, the phase 2 study is still ongoing, and phase 3 has already been initiated based on the interim results in phase 2. The drug showed no new safety signal and no serious adverse events were reported. The ones exhibited were predominantly mild or moderate and included upper respiratory tract infection, nasopharyngitis, and acne. Overall, Baricitinib demonstrated substantial improvement over existing therapies in the trial. The breakthrough status accelerates the development and review of the drug ensuring faster launch in the market upon approval.
Dory Kranz, the president and CEO of the National Alopecia Areata Foundation expressed his happiness over the news. “This drug brings hope to millions of people affected with AA around the world. We’re encouraged by Baricitinib’s potential to be one of the first FDA-approved medicines to treat AA” he said.
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