Euro Roundup: EMA proposes updating psoriatic arthritis trial guidance for first time since 2007

The European Medicines Agency (EMA) is seeking feedback on plans to revise its guideline on the clinical investigation of psoriatic arthritis treatments for the first time since 2007.

Psoriatic arthritis is a chronic inflammatory disease that requires early treatment to stop inflammation from causing joint damage. EMA brought its current guideline on studying treatments into force in 2007. Since then, the agency has approved several medicinal products for the treatment of psoriatic arthritis.

EMA discussed how the landscape has changed in a draft concept paper, explaining that there have been “substantial updates in general treatment approaches and treatment goals for this condition.” However, “patients experiencing poor efficacy and tolerability of current therapies” still need new treatments.

The current guidance on the development of such treatments does not take into account the regulatory experience with applications for scientific advice and for marketing authorization that EMA has gained since 2007, nor does it reflect the available treatments or developments in early disease detection.

“In particular, the European League Against Rheumatism (EULAR) recommendations for the treatment of [psoriatic arthritis] have been published and most recently updated,” EMA said. “EULAR points to consider for the definition of clinical and imaging features suspicious for progression from psoriasis to [psoriatic arthritis] also need to be considered.”

EULAR developed recommendations for the pharmacological management of psoriatic arthritis in 2011 and has updated them three times. EMA highlighted three important points in the recommendations that its guideline fails to reflect or sufficiently address.

The most recent EULAR document says the goal of treatment should be remission or low disease activity. EULAR called for the regular assessment of different aspects of disease activity, such as the effect on the joints and skin, and the adjustment of treatment to reflect the predominant manifestation of the disease at a given moment.

“Overall, a rather substantial revision of the guideline section on ‘Methods to assess efficacy’ is expected, reflecting also validation and use of new endpoints in authorization studies as compared to 2007 when the current guideline came into effect,” EMA said. “It is foreseen that the recommendation for the primary endpoint will be updated.”

EMA also noted EULAR recommendations about the need to choose treatments based on both the musculoskeletal subtype of psoriatic arthritis and other manifestations related to the condition, such as skin psoriasis, uveitis and inflammatory bowel disease. The agency said the topic is covered “to some extent” in the current guideline but could be “further highlighted” in the updated document.

The third important EULAR point noted by EMA is the recommendation to consider reducing the dose of disease-modifying antirheumatic drugs when a patient is in sustained remission. EMA said the topic is not explicitly covered in the current guideline.

EMA is accepting feedback until 30 September.

Concept Paper

MDCG changes MDR and IVDR guidance on standardization for medical devices

The Medical Device Coordination Group (MDCG) has updated its guidance on standardization for medical devices, adding points on topics including the European Pharmacopoeia and common specifications.

MDCG published the original document in 2021 to provide guidance on aspects related to standards in the medical devices sector. The guidance covered topics such as the general framework for harmonized European standards and how they support legislation on medical devices. MDCG recently revised the text for the first time.

The group added a subsection on the European Pharmacopoeia, in which it explains the relationship between monographs and the Medical Device and In Vitro Diagnostic Regulation (MDR/IVDR). Another new subsection outlines what references to “common specifications” in MDR and IVDR mean for medical device and diagnostic companies.

MDCG also added a point on the Court of Justice of the European Union’s rulings on standardization. The new subsection describes six rulings that affect standardization of medical devices, such as a decision in the “Orona” case that confirmed a manufacturer is allowed to choose equivalent alternative solutions to those prescribed by harmonized standards.

The guidance features revisions to existing sections. MDCG has added text about references to ISO standards in MDR and IVDR. In the diagnostic regulation, a reference to a standard on the quality and competence of medical laboratories “is related to the scope and applicability of IVDR requirements under specified conditions, but not to any presumption of conformity,” MDCG said.

MDCG Guidance

In a first, NICE recommends reimbursement under managed access agreement

The UK National Institute for Health and Care Excellence (NICE) recommended a drug receives managed access through the Innovative Medicines Fund for the first time.

Managed access is intended to accelerate access to promising new treatments. Through the program, NHS England and the drugmaker agree conditions under which people will be able to receive a therapy and how data will be collected to address uncertainties in the clinical- or cost-effectiveness data. The arrangements last for up to five years, less if the collected data can address the uncertainties sooner.

NICE established the program in 2022. Last week, CSL Behring’s hemophilia B gene therapy Hemgenix became the first product to be granted managed access. Paul Catchpole, director of value and access policy at trade group ABPI, welcomed the agreement.

“We hope we will see more new medicines reaching patients through this pathway in the future,” Catchpole said. “It is also encouraging to see an innovative payment model has been agreed, with payments potentially linked to how well the treatment performs over time.” Catchpole said the model could become more important for some medicines in the coming years.

Press Release, ABPI Notice

Swissmedic updates authorization forms to raise the standard of submissions

The Swiss Agency for Therapeutic Products (Swissmedic) has explained what information applicants need to provide about their targeted indication in filings for authorizations, variations and extensions.

Swissmedic publishes the information applicants submit about their indications. The agency said the “level of detail of this information varies greatly, and that the information provided is insufficient in some cases.” In response, the Swiss regulator has updated its authorization forms to clarify the information that applicants should provide.

The agency is asking applicants to either provide the proposed wording of the indication or a summary that includes certain information. The list of requested information includes specification of the disease, line of treatment, type of prior therapies and target population.

“If applicants claim there is commercially confidential information in the formulation of the indication, the cumulative, case-specific requirements will apply; the legitimacy of these will be checked by Swissmedic,” the agency said. “Swissmedic has also simplified the consent to sharing information with partner authorities.”

Swissmedic Notice

Other News:

Swissmedic has reduced the fees for processing applications for non-commercially funded clinical trials by 80%. The agency cut its fee in response to requests from Parliament and the Federal Council, which want to promote non-commercial research. Swissmedic said sponsors must confirm that no commercial third-party funds are being used to carry out all or part of the trial to qualify. Swissmedic Notice, More

Swissmedic has stopped granting exceptions to products used to treat or prevent COVID-19. The agency created a rolling authorization procedure for such products and allowed them to convey information via QR codes, rather than paper, to support quick approval and deployment during the pandemic. However, the legislation that supported the exceptional measures lapsed at the end of June. Swissmedic Notice

Euro Roundup: EMA proposes updating psoriatic arthritis trial guidance for first time since 2007

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