Eli Lilly & Co. is gearing up for a second-quarter launch of its psoriasis drug Taltz (ixekizumab), and while the IL-17 inhibitor class has been well received in the dermatology community, Lilly faces a lot of competition and a challenging reimbursement environment.

FDA approved Taltz, which binds to the protein interleukin-17A, for adults with moderate-to-severe plaque psoriasis on March 22. The drug was previously recommended for approval for treating psoriasis in Europe in February Also see "EU Committee Nod For Lilly's Ixekizumab In Psoriasis" - Pink Sheet, 29 February, 2016..

Taltz’ US approval was supported by the three pivotal trials, which included 3,866 patients with moderate-to-severe plaque psoriasis ([A#14140821005]). In the program, ixekizumab was compared against placebo and also head-to-head against Amgen Inc.’s TNF inhibitor Enbrel (etanercept).

Lilly said that it will be ready to launch in the US sometime in the second quarter and did not disclose price.

Novartis AG’s first-in-class IL-17A inhibitor Cosentyx (secukizumab) cleared FDA for psoriasis in February 2015, after a unanimous recommendation from the Dermatologic and Ophthalmic Drugs Advisory Committee ([A#14141020005]). The company reported sales of $261m in 2015. Cosentyx was approved in January for additional indications in psoriatic arthritis and ankylosing spondylitis ([A#00160125012]).

Lilly is also developing ixekizumab for psoriatic arthritis and has released positive pivotal data for this indication ([A#14150420001]). The company says it is planning to start a new study in ankylosing spondylitis, but it hasn’t been listed on the ClinicalTrials.gov website yet.

The market for psoriasis drugs is challenging because TNF inhibitors like Enbrel, AbbVie Inc.’s Humira (adalimumab) and Johnson & Johnson’s Remicade (infliximab) are entrenched and doctors are highly safety-conscious.

New classes are also now available, like Johnson & Johnson’s IL-12/IL-23 inhibitor Stelara (ustekinumab), which has proven very successful, with worldwide sales of $2.4bn in 2015, following approval in 2009, and has built up trust with dermatologists.

Still, data for IL-17 inhibitors had a very good reception at the American Academy of Dermatology annual meeting in 2015, particularly head-to-head data showing superiority for both Cosentyx and Amgen Inc./AstraZeneca PLC’s brodalumab against Stelara ([A#00150330003]). (Brodalumab was later associated with a troubling suicide signal and rights were licensed to Valeant Pharmaceuticals International Inc.[See Deal].)

The head-to-head data arguably gives Cosentyx an advantage, though on the other hand, the data may be interpreted as a beneficial class effect. Lilly is running an ex-US Phase III study of ixekizumab against Stelara; the primary completion date is July 2016.

While the IL-17 data were well-received at the AAD meeting, specialists cautioned that they would like to see long-term safety data for IL-17 inhibitors and noted that regardless of what doctors and patients want, reimbursement often dictates the treatment choice.

The TNF inhibitors are approved for a range of indications and benefit from broad payments across indications. New classes are typically subject to step therapy starting with TNF inhibitors and prior authorization ([A#00150601003]).

In addition to IL-17 inhibitors, other new classes are on the near horizon for psoriasis and other inflammatory conditions, with the interleukin-23 inhibitor class looking particularly promising. J&J’s guselkumab is in Phase III. AbbVie Inc. announced a deal to pay $595m upfront to Boehringer Ingelheim GMBH for its selective Phase III anti-IL-23 antibody BI655066 in March ([A#14160307004]).

Lilly’s Psoriasis Drug Taltz Set For Second Quarter Launch

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