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Manila Times Business

Novartis receives European Commission approval for Cosentyx® in polymyalgia rheumatica (PMR)

Cosentyx® (secukinumab) becomes first and only IL-17A inhibitor approved in Europe for adults with PMR,1 a common inflammatory rheumatic disease with limited advanced treatment options2-6Approval based on Phase III REPLENISH trial showing Cosentyx doubled sustained remission rates vs placebo at Week 52; safety results consistent with established Cosentyx profile7Additional regulatory reviews of Cosentyx in PMR ongoing globally, including in US and JapanBasel, October 21, 2026 - Novartis announce

Context & Analysis

Polymyalgia rheumatica affects older adults, causing pain and stiffness in the shoulders, neck, and hips. It is treatable but often poorly managed, with many patients cycling through corticosteroids that carry their own long-term risks. For the Philippines, where the population is aging and autoimmune disease prevalence is climbing, the arrival of a new class of treatment in Europe signals a shift that will eventually reach local shelves and hospital formularies.

The Philippine pharmaceutical market has been growing steadily, driven by rising middle-class healthcare spending and a government push to expand insurance coverage. Yet the pipeline for specialty biologics — complex drugs like secukinumab that target specific immune pathways — moves through the Philippine FDA on a longer timeline than in Europe or the United States. The country's regulatory authority has modernized considerably in recent years, adopting ICH guidelines and streamlining review processes, but a new approval in Brussels still typically means patients here wait months or even years before the same product is registered locally.

This matters for a specific set of Philippine businesses. Local distributors and importers of specialty pharmaceuticals, including companies partnered with multinational manufacturers, watch these approvals as leading indicators of revenue opportunities. A new indication in Europe often precedes a new indication filing in the Philippines, which in turn opens a fresh commercial channel. Hospitals and HMOs also take note, because specialty drug procurement decisions depend on whether a product has established regulatory backing in major reference markets.

The harder question for Filipino patients remains access and affordability. Biologics of this type carry price tags well beyond what PhilHealth covers for rheumatologic conditions. Even when a drug is technically available, out-of-pocket costs can put it out of reach for all but the wealthiest patients. The Universal Health Care Law, which took effect in 2019, was designed to address gaps like this, but implementation for high-cost specialty medicines has been slow and uneven.

What to watch next: whether the US and Japanese approvals mentioned in the announcement come through on schedule, and whether the Philippine FDA initiates its own review in parallel. If those regulatory dominoes fall, the commercial groundwork for local availability begins in earnest.

Analysis by IJE Software — original commentary on the story above.

This is an excerpt. Read the full article at the original source:

Source: manilatimes.net

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