European CHMP Recommends Approval for 12 New Drugs, Including J&J's Psoriasis Treatment Icotyde and Roche's Ophthalmology Drug Susvimo
Strategic Expansion of the European New Drug Pipeline
The European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a total of 12 new drugs for marketing authorization in Europe during its July 2026 meeting. This recommendation marks a significant milestone, demonstrating that innovative drug delivery platforms and targeted therapies have proven their clinical efficacy and are entering the commercialization phase. In particular, a significant number of oral formulations and sustained-release devices, which maximize patient convenience, have received positive opinions, leading the trend change in the next-generation bio market. The visualization of regulatory approval will lead to the recovery of research and development (R&D) investment costs and the generation of revenue, which will act as a key driver for improving corporate value.
Clinical Value of Icotyde, the First Oral IL-23 Inhibitor
Johnson & Johnson's (Janssen-Cilag/JNJ) psoriasis treatment, Icotyde (active ingredient: icotrokinra), has received a positive opinion as the first oral interleukin-23 (IL-23) receptor ligand. Existing psoriasis treatments, such as Skyrizi, which have led the market, have been injectable, which has been a burden for patients. Icotyde, on the other hand, is an oral drug that is taken once a day, significantly improving patient convenience. In the Phase 3 ICONIC trials, it showed superior skin improvement compared to Sotyktu, a competing oral drug from Bristol Myers Squibb (BMS), securing a commercial advantage. J&J estimates the peak sales potential of this drug to be over $5 billion and plans to expand its indications in the future.
Susvimo, an Innovative Ophthalmology Drug, Revived with a Sustained-Release Platform
Roche's (RHHVY) wet age-related macular degeneration (nAMD) treatment, Susvimo (active ingredient: ranibizumab), has received a positive opinion in Europe in combination with a refillable intraocular implant (Contivue Implant). Susvimo underwent a voluntary recall in 2022 due to a septum detachment issue, but it has successfully overcome the regulatory hurdles after improving the septum design. Unlike existing nAMD standard treatments, such as Eylea, which require frequent direct injections into the eye, Susvimo is a novel platform that only needs to be refilled once every six months, improving patients' quality of life. This is a significant advancement not only in drug improvement but also in establishing the safety of drug delivery platform technology.
Synergies in Targeted Cancer Therapies and Other Drug Pipelines
AstraZeneca (AZN) and Daiichi Sankyo (DSNKY)'s HER2-targeted antibody-drug conjugate (ADC) Enhertu (active ingredient: trastuzumab deruxtecan) and Perjeta (active ingredient: pertuzumab) combination therapy has expanded its indications to first-line treatment for HER2-positive metastatic breast cancer. This recommendation for expanded indications solidifies its position as a next-generation standard of care and demonstrates a strong foundation for driving revenue growth for multinational pharmaceutical companies. In addition, Lynavoy (active ingredient: linerixibat), developed by GSK and licensed to Alfasigma, has been added to treat pruritus in primary biliary cholangitis (PBC), helping to fill the treatment gap in rare diseases in Europe.
This CHMP recommendation for new drug approvals will pave the way for final marketing authorization by the European Commission (EC) in the second half of the year, alleviating short-term regulatory risks for these companies and securing visibility for European sales. In particular, J&J's Icotyde, targeting a $5 billion market for plaque psoriasis, is expected to establish leadership in the oral psoriasis treatment market by securing superior Phase 3 data compared to BMS's Sotyktu. Furthermore, Roche's Susvimo, which overcame the 2022 recall issue and is back on track for re-approval, demonstrates the clinical practicality of sustained-release drug delivery systems and is expected to promote long-term R&D investment in the field of bio-convergence medical devices. Moreover, as seen in the case of Alfasigma, an Italian pharmaceutical company that acquired global rights to Lynavoy for $690 million, large-scale licensing deals and strategic partnerships between large corporations and small biotech companies strengthen the diversification and virtuous cycle of capital recovery in the venture capital (VC) industry. Ultimately, this CHMP's series of positive opinions, coupled with the global trend of declining interest rates, will promote the inflow of venture capital into the bio sector and support the momentum of technology exports for new drug developers.