March 2021 • PharmaTimes Magazine • 8-9
// MEDICINE //
MHRA consults on OTC contraceptive
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on the potential reclassification of two progestogen-only, oral contraceptive pills containing desogestrel: Lovima 75mcg and Hana 75mcg film-coated tablets.
The Agency is asking the public, as well as stakeholders, for their views and opinions on whether the two tablets should become pharmacy medications, available over the counter without a prescription.
If the outcome of the public consultation leads to the reclassification of these two products, pharmacists will have access to training materials as well as a checklist which will allow them to identify which women can receive this medicine safely.
HRA Pharma, which owns the Hana brand, said it supports the decision to launch the public consultation. “This reclassification will offer women more contraception options that do not require a GP appointment or prescription, helping to provide more convenient and regular access for some women.”
The Royal Society of Pharmacists has also welcomed the move. “Pharmacies already play an important role in provision of contraception and are a convenient, expert source of help and advice,” noted its president Sandra Gidley. “This move will increase access to an effective method of contraception and enable women to make an informed choice about their needs after discussion with a pharmacist.
“Whilst this classification is a positive move, ultimately we’d like to see contraceptive services commissioned by the NHS through pharmacies so many more people can benefit from another point of access to contraception and advice.”
UK approves new breast cancer therapy
AstraZeneca and Daiichi Sankyo’s antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has been granted a conditional marketing authorisation in the UK for certain breast cancer patients.
The decision allows use of Enhertu as a monotherapy for the treatment of adults with unresectable or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens.
The UK authorisation is based on results from the Phase II DESTINY-Breast01 trial, in which patients treated with Enhertu demonstrated a confirmed objective response rate of 61.4%, as well as a 6.5% complete response rate and a 54.9% partial response rate. In addition, after a median follow-up of 20.5 months, the median duration of response was 20.8 months.
“The DESTINY-Breast01 trial showed a duration of response not previously seen in patients after progression on first- and second-line treatment,” said Arun Krishna, head of oncology, AstraZeneca UK. “Enhertu is an important new treatment option for patients at this stage of care and will shift clinical discussions towards a focus on targeted treatment. This is the first new cancer medicine to be authorised by the MHRA in 2021 and our focus now is on securing access for NHS patients as quickly as possible,” he added.
The UK’s National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) are both currently appraising Enhertu, with NHS access decisions expected later in 2021.
Pfizer's atopic dermatitis drug joins EAMS
People living in the UK with severe atopic dermatitis are to be given early access to Pfizer's abrocitinib following a green light by the Medicines and Healthcare products Regulatory Agency (MHRA) for the drug's inclusion in the Early Access to Medicine Scientific (EAMS).
The drug is a JAK 1 inhibitor used to treat adult and adolescents with severe atopic eczema (also called atopic dermatitis or AD) who have failed to respond to the approved treatments or who are ineligible or intolerant to them.
In clinical trials, abrocitinib significantly reduced the severity of eczema lesions as well as reducing their extent versus placebo in patients with moderate or severe AD. In two studies, 40-45% of patients given abrocitinib 100 mg and 61-63% of those given 200mg had a meaningful reduction in EASI score compared to 10-12% of those given placebo, after 12 weeks of treatment.
On the safety and tolerability side, the most common side effects with abrocitinib are nausea, cold sores (herpes simplex), vomiting, upper abdominal pain, headache, dizziness, acne and an increase in blood levels of creatinine phosphokinase.
Also, as abrocitinib acts on the body’s immune system, few patients may have infections such as a painful skin rash with blisters (shingles), or a rapidly spreading painful rash, blisters or sores (withor without fever) known as eczema herpeticum. The drug can also cause uncommon but serious side effects including serious infections and blood clots in the lungs, legs or pelvis.
However, the MHRA said the risks of the drug can be managed and do not outweigh the benefits, and so it is being made available to patients of greatest need via the EAMS
Asthma relievers overuse boosting greenhouse gases
Overuse of short-acting beta2-agonist (SABA) relievers for asthma in the UK is responsible for 250,000 tonnes of greenhouse gas emissions – or CO2 – every year, according to a new analysis.
The findings, based on SABA prescription and use data extracted from the UK study in the SABA Use IN Asthma (SABINA) global programme of large-scale observational studies collected between 2007-2017, also show that 83% of all SABA relievers for asthma are prescribed to patients who are potentially overusing their reliever medication.
The prescription of three or more SABA inhalers per year is linked with poor asthma control, around twice the number of exacerbations compared with low SABA users, and increased asthma-related healthcare utilisation.
“Overuse of reliever inhalers in asthma is widespread in the UK and associated with an increased risk of exacerbations for patients, highlighting the importance of adopting strategies to improve disease control and reduce short-acting beta2-agonist overuse,” noted Alexander J K Wilkinson, consultant in Respiratory and General Medicine, East and North Hertfordshire NHS Trust, Stevenage, UK and lead author of the study. “This new analysis shows that reliever overuse is also a major contributor to greenhouse gas emissions in respiratory care, similar to driving an average diesel car for about 900 million miles”.