It has been an active quarter in the immune & inflammatory space for drug developers. A series of approvals, launches, and set-backs could have profound implications for auto-immune, gastrointestinal, and respiratory markets. DRG will be tracking a number of these key events during 2017.
JAK’ing up the heat in the European Rheumatoid Arthritis market
In contrast to the U.S., where Pfizer’s Xeljanz (tofacitinib) was first approved in 2012, JAK inhibitors had not previously reach the key European markets. However, since February, two members of this drug class—Xeljanz and Eli Lilly’s Olumiant (baricitinib)—have won regulatory approval for rheumatoid arthritis (RA) from the European Commission setting up a head-to-head competition in this region. While Olumiant has performed relatively well in clinical trials, especially against AbbVie’s Humira (adalimumab) as an active comparator, European physicians may be influenced by Xeljanz’s availability for multiple years in the United States. Furthermore, market access will play an important role and the level of coverage and restrictions placed on these drugs in the various European markets will be key to their usage in the crowded RA market. Also, with the growing availability of biosimilars, pricing will become increasingly important in local HTA decisions.
DRG will be exploring these issues, and others impacting the RA market in our 2017 Rheumatoid Arthritis EU5 Access & Reimbursement Report, publishing later this year. This report will include primary research among EU5 rheumatologists and payers and will focus specifically on issues pertaining to market access.
Pfizer, Sanofi, and Regeneron hope that their new drugs will scratch patients’ itches
Swiftly following FDA approvals, Pfizer and Sanofi/Regeneron launched their novel atopic dermatitis agents in the U.S. hoping to take advantage of the high unmet need for drugs capable of managing this under-treated condition. Pfizer’s Eucrisa (crisaborole), a topical PDE-4 inhibitor, will primarily target the milder portion of the population who are currently treated with topical corticosteroids or calcineurin inhibitors. Eucrisa may in-particular enjoy use in the pediatric population (the drug is approved for patients over 2 years of age), in whom there are specific concerns about the risk of chronic steroid use causing developmental issues. In contrast, Sanofi/Regeneron’s Dupixent (dupilumab), a biologic which inhibits signaling of IL-4/IL-13, will be targeted at adult patients with moderate to severe atopic dermatitis whose disease cannot be controlled with topical therapies. The launch of these agents is likely to revolutionize treatment of atopic dermatitis, increase awareness of the condition, and spur further development for this historically underserved market.
DRG will be tracking uptake and evolving physician sentiment for Eucrisa and Dupixent in two content series planned for release over the next year: Emerging Therapies Eucrisa and Emerging Therapies Dupixent. These two series will comprise three Waves each based on primary market research conducted among dermatologists at one month, six months, and twelve months following the drugs’ respective launches.
Given the activity in this market, we will be publishing atopic dermatitis content throughout the year including Atopic Dermatitis Unmet Need, Atopic Dermatitis US Access & Reimbursement, Atopic Dermatitis EU5 Access & Reimbursement, and Atopic Dermatitis Disease Landscape & Forecast.
Air is knocked out of Mylan’s sails
Ever since the FDA issued draft guidance for a substitutable generic version of Advair (salmeterol/fluticasone propionate) back in 2013, there has been speculation around when the first generic to GSK’s market-leading therapy would reach the market. At that time, the FDA’s stance was considered to have lowered the bar for winning generic approval to a more easily attainable level than had been previously expected. Nevertheless, the most advanced candidate, which is in-development by Mylan, fell at the first hurdle with the FDA issuing a CRL in late-March. Colleen Albacker, a Director in DRG’s Immune & Inflammatory team, has produced a blog post outlining the implications for GSK, Mylan, and other developers of generic formulations of Advair. Her thoughts can be found here.
DRG will be monitoring this situation closely. After the launch of the first substitutable generic salmeterol/fluticasone propionate we plan to survey pulmonologists at intervals of one, six, and twelve months post-launch about their usage and opinions regarding these new formulations. These findings will be published as part of the series, Emerging Therapies Salmeterol/fluticasone propionate generics.
In other news….
In March, the European Commission approved Amgen’s biosimilar of AbbVie’s Humira, Amjevita, for a range of immune and inflammatory conditions. This follows an earlier approval by the FDA in September 2016. Another biosimilar to Humira, Boehringer Ingelheim’s BI 695501, is currently under review by both the EMA and FDA.
The FDA approved Valeant’s third-in-class IL-17 inhibitor Siliq (brodalumab) in February for the treatment of moderate to severe plaque psoriasis. This approval follows a difficult path to approval with both Amgen and AstraZeneca electing to cease development of the drug after an association with suicidal ideation in Phase III studies. Siliq will compete directly with Novartis’s Cosentyx (secukinumab) and Eli Lilly’s Taltz (ixekizumab) which launched in the U.S. in 2015 and 2016, respectively. Sangha Mitra, a Senior Business Insights Analyst at DRG, discussed other key dermatology news from the American Academy of Dermatology conference held in March in a recent blog which can be found here.