MHRA Approves Pierre Fabre's Vibegron for OAB Treatment

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light to Pierre Fabre’s vibegron, marketed under the name Obgemsa, for the treatment of overactive bladder (OAB) syndrome symptoms in adults. This condition is characterized by symptoms such as urgency, increased urinary frequency, and incontinence. Vibegron is a beta 3 adrenergic receptor agonist, which acts as a muscle relaxant for the bladder, thereby reducing excessive bladder activity.

The recommended dosage for vibegron is a 75mg film-coated tablet taken daily. The MHRA's approval is based on data derived from the Phase III EMPOWUR clinical trial, which evaluated the drug's efficacy and safety over a 12-week period in 1,515 patients suffering from OAB. Participants in the trial were divided into three groups, receiving either a placebo, a 75mg dose of vibegron, or an active control.

The trial results were promising. Patients who were administered vibegron experienced a substantial reduction in the number of daily urination and incontinence episodes compared to those who received the placebo. Notably, these improvements were evident within just two weeks and were maintained throughout the treatment period. However, some patients did report side effects which included headaches, diarrhea, constipation, nausea, urinary tract infections, and increased post-void residual urine volume.

The MHRA has committed to ongoing surveillance of vibegron’s safety and efficacy, urging healthcare professionals and patients to report any adverse effects through the Yellow Card scheme. This ensures that any potential issues can be monitored and addressed promptly, maintaining the drug's safety profile.

In addition to vibegron, the MHRA has also approved a new treatment for advanced HR-positive, HER2-negative breast cancer with specific genetic abnormalities. AstraZeneca’s capivasertib, sold under the name Truqap, has been sanctioned for use in patients whose cancer has not responded to other treatments. Capivasertib is an AKT inhibitor that works by hindering the proliferation of cancer cells and is taken orally in combination with fulvestrant, a hormonal therapy.

The approval of capivasertib was underpinned by a clinical trial that included 708 patients, with a specific focus on a subset of 289 patients displaying the targeted genetic mutations. Results from the clinical studies revealed that individuals treated with capivasertib had an average progression-free survival of 7.3 months, compared to just 3.1 months for those who received a placebo. Despite its effectiveness, the drug is associated with potential side effects such as high blood sugar, diarrhea, skin rashes, urinary tract infections, low blood hemoglobin levels, appetite loss, nausea, vomiting, mouth sores or ulcers with gum inflammation, itching, and fatigue.

Both vibegron and capivasertib offer new hope for patients dealing with challenging health conditions. The MHRA’s approvals of these medications reflect ongoing advancements in medical treatments and underline the importance of rigorous clinical trials in establishing the efficacy and safety of new therapeutic options.