Pharmaceutical Market Europe • March 2023 • 6-7
NEWS
FDA external report recommends actions to address US opioid crisis
The US Food and Drug Administration (FDA) has published a new external report recommending three actions the agency should take to address the US drug overdose and substance use disorder crisis, primarily relating to opioids.
More than 107,000 Americans died from a drug overdose in 2021, according to the US Centers for Disease Control and Prevention, of which over 70,000 were as a result of using synthetic opioids containing fentanyl.
The External Review of FDA Regulation of Opioid Analgesics Final Report analysed the FDA’s implementation of the 2017 National Academies of Sciences, Engineering, and Medicine’s (NASEM) recommendations – a project also related to opioid prescribing issues – along with key regulatory policies and decisions.
The new report recommends the agency continues its efforts to implement the recommendations in the NASEM report, including evaluating study designs to inform an approach for regulatory decision-making that incorporates public health considerations.
It is also recommended that the FDA considers seeking certain additional government authorities regarding opioid approvals and review of the advertising and promotion for such products.
The third recommendation advises the agency to be ‘as transparent as possible’ regarding decision-making for opioids in order to encourage appropriate use, promote innovation in pain management and enhance public trust.
Paris Court of Appeal overturns Novartis and Roche’s €444m fine
A €444m anti-competitiveness fine given to Novartis and Roche has been revoked by the Paris Court of Appeal, which ruled that the two companies did not abuse their market power to boost sales of their eye disease drug Lucentis.
The Autorité de la Concurrence first levied the fine on the companies in 2020, with the French competition authority charging the pair with illegally preventing the off-label use of an older and cheaper alternative drug to treat wet age-related macular degeneration (AMD).
Despite not being approved for wet AMD, Roche’s Avastin had been shown to be effective in treating the condition and, as the cancer drug is significantly cheaper that Lucentis, there was a push for its off-label use in this indication.
In response, Novartis and Roche launched legal action to block the off-label use of Avastin and allegedly worked to restrict access and spread misleading statements about the risks associated with the drug.
The fine has now been overturned, with the appeals court concluding that the companies had been ‘measured in tone’ in their comments about Avastin’s use in AMD.
The court also ruled that Roche’s refusal to supply samples of Avastin for a comparator clinical trial could not have had an anti-competitive effect.
Merck KGaA and Aqilion AB partner in potential €960m deal
Merck KGaA and Aqilion AB have entered into an exclusive licence and strategic research partnership to advance small molecule inhibitors of the TAK1 protein, thought to play a central role in various inflammatory responses.
Under the terms of the agreement, Aqilion will receive an upfront payment of €10m from Merck KGaA and will be eligible to receive up to €950m in potential milestone payments, as well as tiered royalties on global net sales.
The partnership, which combines the Swedish biotech’s experience in the discovery of selective TAK1 inhibitors with Merck KGaA’s drug discovery and development capabilities, will aim to develop therapeutics for a broad range of autoimmune and inflammatory diseases, including those that are neurological.
Aqilion will be responsible for the design and synthesis of the novel small molecule TAK1 inhibitors, while Merck KGaA will lead preclinical pharmacology and biology studies.
Aqilion’s pipeline currently consists of four programmes in various phases of development, all of which are focused on innovative treatments for chronic inflammatory diseases for which few or no treatments are available.
This includes AQ280, a JAK1 small molecule inhibitor initially being assessed as a potential treatment for eosinophilic oesophagitis, an inflammatory disease
of the oesophagus.
AstraZeneca announces three new European Commission approvals
AstraZeneca has announced three new EU drug approvals, with the company’s Imfinzi/Imjudo immunotherapy combinations authorised for advanced liver and lung cancers, and a tablet formulation of Calquence for chronic lymphocytic leukaemia (CLL).
The Imfinzi/Imjudo approvals authorise the combination for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC), with the addition of platinum-based chemotherapy for adults with metastatic non-small cell lung cancer (NSCLC).
The European Commission’s decision, which follows a recommendation by the Committee for Medicinal Products for Human Use (CHMP), was supported by positive results from the HIMALAYA and POSEIDON phase 3 trials.
In HIMALAYA, the combination was associated with a significant reduction in the risk of death in HCC patients, at 22% versus standard of care sorafenib.
Results from POSEIDON showed a 23% reduction in risk of death of NSCLC patients treated with the combination plus four cycles of platinum-based chemotherapy, versus a range of chemotherapy options.
The new approval for Calquence, which also follows a recommendation from the CHMP, was based on the ELEVATE-PLUS trials.
Results showed the capsule and tablet formulations of the drug were bioequivalent, indicating the same efficacy and safety profile can be expected when prescribed with the same dosing strength and schedule.
EC approves UCB’s Fintepla to treat severe form of epilepsy
The European Commission (EC) has approved UCB’s Fintepla oral solution as an add-on treatment for seizures associated with Lennox-Gastaut syndrome (LGS), a severe form of epilepsy.
The disease, which affects around two in 10,000 people in the EU, usually begins in early childhood and is characterised by multiple types of drug-resistant seizures with high morbidity, as well as serious impairment of neurodevelopmental, cognitive and motor functions.
The EC’s decision, which indicates the therapy for patients aged from two years, was based on phase 3 trial results showing that a daily dose of Fintepla, in combination with other anti-epileptic medicines, provided a significantly greater reduction in the frequency of seizures leading to falls compared to placebo.
The most common treatment-emergent adverse events were decreased appetite, fatigue and fever, the company reported, and no cases of valvular heart disease or pulmonary arterial hypertension were observed.
Along with its approval, the EC also adopted the European Medicines Agency Committee for Orphan Medicinal Products’ recommendation that the orphan designation for fenfluramine be maintained.
Fintepla is already approved in the US for the treatment of seizures associated with LGS, as well as for Dravet syndrome – a rare and severe form of epilepsy – in the EU, the US and Japan.
UN report highlights role of pharma pollution in AMR threat
A new report from the UN Environment Programme (UNEP) has provided evidence that pollution created by the pharmaceutical, healthcare and agricultural sectors ‘plays a key role’ in the development and spread of antimicrobial resistance (AMR).
The report, Bracing for Superbugs: Strengthening environmental action in the One Health response to antimicrobial resistance, calls for a ‘multisectoral response’ to AMR, which is listed by the World Health Organization as one of the top ten threats to global health.
The report from UNEP explains that the increased use and misuse of antimicrobials and other microbial stressors, such as pollution, create favourable conditions for microorganisms to develop resistance both in humans and the environment from sources such as sewage.
In the case of the pharmaceutical sector, pollution can come from manufacturing facilities and the entry of excreted drug products into wastewater systems.
Seeking to tackle the problem, the report proposes a set of measures to address both the decline of the environment and the rise of AMR.
This includes improving water management and sanitation, integrating environmental considerations into AMR national action plans and developing international standards for what constitutes a good microbiological indicator of AMR from environmental samples.
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