Merck Receives Recommendation for Approval in 21 EU Countries for the New Formulation of Euthyrox(R)

PR74542

DARMSTADT, Germany, July 26, 2018, /PRNewswire=KYODO JBN/--

Not intended for UK- or US-based media

German Federal Institute for Drugs and Medical Devices (BfArM) recommends new

formulation of Euthyrox(R) for approval in 21 EU countries

BfArM is acting as a representative of all 21 EU countries involved in the EU

worksharing procedure

Merck, a leading science and technology company, today announced that the

German Federal Institute for Drugs and Medical Devices has recommended to

approve Merck's new formulation of Euthyrox(R)(levothyroxine) in 21 EU

countries. National approvals will be issued following this recommendation.

"The tighter specification of the active ingredient in the new formulation of

Euthyrox(R) aims to help patients have better control over their individual

levothyroxine dosage," said Steven Hildemann, Global Chief Medical Officer at

the Biopharma business of Merck. "Following the positive recommendation from

BfArM, Merck will continue to collaborate closely with local Health

Authorities, healthcare professionals and patient groups in preparation for the

roll out of the new formulation in the 21 countries. Together with the

respective stakeholders, and in full compliance with the local regulations, we

aim to ensure that patients are appropriately informed. Therefore it is our

first priority to support physicians and help them provide their patients with

the best possible transition to the new formulation of Euthyrox(R)."

The German BfArM decision to recommend the approval of the new formulation of

Euthyrox(R) across 21 EU states was based on a study demonstrating

bioequivalence between the old and new formulations.

Levothyroxine is a synthetically produced hormone that corresponds to the

natural thyroid hormone Thyroxin (T4). It is used to treat hypothyroidism,

goiter and to suppress TSH in the post-treatment of differentiated thyroid

cancer.

The new formulation came at the request of several health authorities

worldwide. It was introduced in France in March 2017 and Switzerland in April

2018. Turkish authorities have approved the new formulation and Merck expects

to launch the medicine there in the course of 2018.

For thyroid drugs a small dosage variation might impact the patient's thyroid

balance. Prescribing doctors are therefore encouraged to monitor patients

closely when prescribing the new formulation and to adjust the individual

dosage if medically required. Along with Health Authorities, Merck recommends

that all patients do not switch or stop their treatment without medical advice

and refer to their prescribing physician to potentially adjust the medication

dose to their individual need during the transition phase.

All Merck Press Releases are distributed by e-mail at the same time they become

available on the Merck Website. Please go to

http://www.merckgroup.com/subscribe to register online, change your selection

or discontinue this service.

About Merck   

Merck is a leading science and technology company in healthcare, life science

and performance materials. Almost 53,000 employees work to further develop

technologies that improve and enhance life - from biopharmaceutical therapies

to treat cancer or multiple sclerosis, cutting-edge systems for scientific

research and production, to liquid crystals for smartphones and LCD

televisions. In 2017, Merck generated sales of 15.3 billion euros in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical

company. The founding family remains the majority owner of the publicly listed

corporate group. Merck holds the global rights to the Merck name and brand. The

only exceptions are the United States and Canada, where the company operates as

EMD Serono, MilliporeSigma and EMD Performance Materials.

Sara Yussefi

+49-151-14546690

Sara.yussefi@merckgroup.com

     (Logo: https://mma.prnewswire.com/media/554117/Merck_Logo.jpg )

Source: Merck