European Regulatory Roundup: EMA Unveils Antimicrobial Strategy (19 November 2015)

Regulatory NewsRegulatory News | 19 November 2015 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

EMA Releases Five-Year Antimicrobial Strategy

The European Medicines Agency (EMA) has released a document outlining how it plans to ensure the availability of effective antimicrobials for animals while minimizing the risks their use poses to humans. EMA is proposing to restrict the administration of certain antimicrobials to humans.

Over the course of the 16-page document, EMA sets out a five-year strategy for managing the threat of antimicrobial resistance without preventing animals from accessing antimicrobials. The proposal includes a plan to create a legal tool that stops veterinarians from prescribing certain antimicrobials to animals. CVMP thinks the action will help humanity retain a pool of antimicrobials that remain an effective last-resort option for the treatment of life-threatening conditions.

A desire to preserve such a collection of effective treatments underpins the six aims at the center of the strategy document. The first goal is to build risk-management measures into recommendations for the approval of new veterinary antimicrobials. In doing so, CVMP is aiming to prevent unsafe and unsustainable use of the products. The strategy extends to ensuring the responsible use of products under the cascade, a model veterinarians use when approved animal antimicrobials are unavailable.

Officials at EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) have committed to the monitoring of the sales and usage of already authorized products, too, while also encouraging the monitoring of the susceptibility of target pathogens. If the risk-benefit of the authorized product is seen to have changed, CVMP will review the approval. Such post-market monitoring is intended to prevent the continued use of antimicrobials that are ineffective or raise the risk of resistance.

In the longer term, EMA is hoping that by providing advice on the public health risks associated with antimicrobial use, finding a way to encourage development of new products, taking steps to cut the need to use such drugs and enlisting the support of global partners, it can improve the situation. The document is open for comment until 29 February 2016.

CVMP Strategy, Press Release, More

NICE Rejects Closely Watched Cholesterol and Cancer Drugs

The United Kingdom National Institute for Health and Care Excellence (NICE) has rejected cancer and cholesterol drugs from Roche and Amgen, respectively. Both drugs are predicted to generate significant sales in the coming years, but NICE has decided they represent poor value to the health service.

Each rejection was underpinned by a different reason. The argument over the reimbursement of the Roche cancer drug that suffered the rejection, Kadcyla, has gone on for months. NICE initially said no to the product in August, after which Roche said the process used for assessment is “broken.” Since then, Roche has agreed to sell Kadcyla to England’s controversial Cancer Drugs Fund at a cut price to ensure its continued reimbursement through the oncology-specific mechanism.

Roche provided a discounted price to NICE, too. However, NICE said the discount was smaller than that offered to Cancer Drugs Fund. “It is disappointing that there appears to have been no meaningful attempt by Roche to reconsider its price to secure Kadcyla’s long-term future in the NHS, outside of the Cancer Drugs Fund,” Sir Andrew Dillon, NICE chief executive, said. Roche’s refusal to offer a bigger discount contributed to Kadcyla failing to meet NICE’s definition of value.

Amgen is facing a different problem with its recently approved cholesterol drug Repatha. The data presented by Amgen have convinced NICE Repatha is effective at reducing levels of LDL cholesterol. However, it is unclear to the NICE reviewers whether this decline in the levels of LDL cholesterol translates into the prevention of angina, heart attacks and strokes. Lacking information on the impact of Repatha on clinical outcomes, NICE has provisionally rejected the drug.

“The committee concluded that the degree of uncertainty in the cost-effectiveness evidence was too high for it to be able to make well-founded recommendations about [Repatha],” Meindert Boysen, program director at NICE, said. Amgen and other interested parties have until 8 December to respond to the preliminary guidance. NICE will consider any responses at a meeting early next year.

NICE Statement, More

CHMP Starts Consultation on Testing Preventions of Venous Thromboembolism

The Committee for Medicinal Products for Human Use (CHMP) has released draft guidance on the clinical development of preventions of venous thromboembolism (VTE) in non-surgical patients. CVMP has drafted the document in response to changes to other EMA guidelines on clinical trials of drugs to prevent the formation of blood clots.

Balancing the need to stop blood clots from forming against the risk of bleeding is central to the clinical development of prophylactics against VTE, a group of common circulatory diseases comprising deep vein thrombosis and pulmonary embolism. CVMP addressed this balance in a guidance text it released in 2006, but since then EMA has released or revised documents covering antithrombotics, the name for the class of drugs that prevent blood clots.

In response to these documents, CVMP has revised its VTE draft. The new text provides updated advice on the role of imaging tests during dose-finding trials and the use of extra secondary safety outcomes, such as hepatic events and arterial thromboembolism. CVMP has also added a discussion about how to handle specific populations, such as acutely-ill nonsurgical patients at high risk of VTE and outpatients with cancer.

The final significant change relates to the updating of the definition of bleeding events since CHMP released its original guidelines. In the new draft, CHMP provides a description of how it thinks clinical trial sponsors should measure blood loss and timing, as well as a standardized definition of bleeding. CHMP is accepting feedback on the draft guidelines until May 15, 2016.

Draft Guidelines

EMA Shares Advice on Labeling Mockup and Review Process

EMA has discussed the labeling mockup and review process at its industry stakeholder platform on the operation of the centralized procedure. The regulator used the event to present its approach to the review of the labels of products for which a company is seeking marketing authorization.

Companies run into some common issues when designing packaging that meets EMA’s standards. The inclusion of logos that affect the legibility of the text, fonts that are too small to read easily and the use of too many colors were all cited as problems by EMA, which gave real-world examples to support its points. EMA also mentioned multilingual packaging as a particular problem. Displaying one language per panel and using standard abbreviations are ways to manage issues of space.

EMA works through these issues during a labeling mockup and review process that runs in parallel to the scientific assessment of applications for marketing authorizations. Representatives of CHMP, the Pharmacovigilance Risk Assessment Committee, healthcare professionals and patients are all involved with the mockup review process, the purpose of which is to deliver labeling that is clear and easy to understand.

EMA Presentation

Other News:

The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has issued an alert relating to Sapphire multi-therapy and epidural pumps, medical devices that are produced by Q Core Medical for distribution by Hospira. The alert was prompted by reports of fluctuation in the accuracy of the flow rate. MHRA Notice

CHMP has adopted a qualification opinion on the use of total kidney volume as a prognostic biomarker in clinical trials involving people with autosomal dominant polycystic kidney disease. CHMP Opinion 


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