The Medicines and Healthcare products Regulatory Agency (MHRA)
has approved a four-dose version (covering a month’s treatment)
of the diabetes and weight management medicine Mounjaro
(tirzepatide) - Mounjaro KwikPen.
Mounjaro KwikPen is approved to treat adults with type 2 diabetes
and for weight management in adult patients with a BMI of 30kg/m²
or more (obesity), as well as those with a BMI between 27-30kg/m²
(overweight) who also have weight-related health problems such as
prediabetes, high blood pressure, high cholesterol, or heart
problems.
The medicine is to be used together with a reduced-calorie diet
and increased physical activity.
Beach, MHRA Interim Executive
Director, Healthcare Quality and Access, said:
“The public health importance of safe and effective treatments to
help manage diabetes and obesity, which can have a significant
impact on people’s health, is clear.
“This approval enables access to the approved Mounjaro pen in a
more convenient presentation of a month’s treatment, of one dose
per week.”
Douglas Twenefour, Head of Care at Diabetes UK,
said:
“We hope the MHRA’s approval of this device will help
people living with type 2 diabetes, who are eligible, to access
this effective treatment.
“Supporting people with type 2 diabetes to lose weight and manage
their blood sugar levels is key to reducing the risk of
diabetes-related complications, and tirzepatide (Mounjaro)
expands the range of treatment options available to help people
achieve this.”
Mounjaro KwikPen is available as a four-dose pre-filled injection
pen containing 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg and 15mg of
tirzepatide per dose, injected under the skin of a patient’s
stomach area, thigh or upper arm.
Starting dose is 2.5mg once a week for four weeks, increasing to
5mg once a week. The dose may then be increased in at least
4-week intervals up to the maximum dose of 15mg once weekly, if
recommended by the patient’s doctor.
How it works
The active ingredient in this treatment, tirzepatide, helps to
reduce sugar levels in people with type 2 diabetes only when the
levels of sugar are high.
It also regulates a patient’s appetite, so they feel full, making
them feel less hungry and experience fewer food cravings.
Evidence base
The approval of Mounjaro Kwikpen is based on the results of a
bridging study, which provided evidence that the efficacy and
safety of the multidose Mounjaro Kwikpen are expected to be the
same as those for the single-dose Mounjaro pen that is approved
based on seven global clinical trials.
Five of these trials (SURPASS 1-5), involving 6,263 participants
in total, looked at the safety and efficacy of the active
ingredient tirzepatide in participants with type 2 diabetes.
Across all the studies, participants who received tirzepatide
showed significant decreases in fasting glucose levels compared
to either placebo or an active control (semaglutide, insulin
degludec and insulin glargine) for up to 1 year. In one study
these effects were sustained for up to 2 years. Significant
decreases in body weight were also demonstrated.
Two of these trials (SURMOUNT 1-2), involving 3,477 participants
in total, looked at safety and efficacy of tirzepatide when used
for weight management (reduction and maintenance) in overweight
and obese adults with and without diabetes. In both studies,
overweight or obese adults treated with tirzepatide saw
significant reductions in body weight compared to placebo,
irrespective of age, sex, race, ethnicity, baseline BMI and
glycaemic (status).
Side effects
The most common side effects of the medicine are nausea,
diarrhoea, vomiting (which usually goes away over time), and
constipation. Low blood sugar (hypoglycaemia) is also very common
in patients with diabetes. Symptoms of this can include headache,
drowsiness, weakness, dizziness, feeling hungry, confusion,
irritability, fast heartbeat and sweating.
Obese or overweight female patients using oral contraceptives
should consider also using a barrier method of contraception
(e.g., a condom) or switching to a non-oral contraceptive method
for 4 weeks after starting Mounjaro and for 4 weeks after each
increase in dose as Mounjaro may affect how well the
contraceptive pill works in these patients.
As with any medicine, the MHRA will keep the safety and
effectiveness of Mounjaro under close review. Anyone who suspects
they are having a side effect from this medicine are encouraged
to talk to their doctor, pharmacist or nurse and report it
directly to the Yellow Card scheme, either through the website
(https://yellowcard.mhra.gov.uk/)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
Notes to editors
- This line extension was granted on 25 January 2024 to Eli
Lilly Nederland B.V.
- More information can be found in the Summary of Product
Characteristics and Patient Information leaflets which will be
published on the MHRA Products
website within 7 days of approval.
- For more information about the SURPASS or SURMOUNT studies,
see the Summary of Product Characteristics.
