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In the UK, the pathway to approval typically involves: Submission of a Marketing Authorisation Application (MAA) to the MHRA Scientific review of clinical trial data, including safety, efficacy, and quality data Benefit-risk assessment by MHRA experts If approved, a subsequent NICE technology appraisal to determine whether the medicine represents value for money and should be made available within the NHS The MHRA also operates an Early Access to Medicines Scheme (EAMS) , which can allow patients with life-threatening or seriously debilitating conditions to access promising unlicensed medicines before full approval
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Furthermore, Ozempic is not recommended for pregnant women or those planning to become pregnant due to potential risks to the developing fetus
Lawsuits against Novo Nordisk, the manufacturer of Ozempic, allege the pharmaceutical giant knew or should have known the drug carried a significant risk of harm for users
