[Grandbrothers - stock.adobe.com]
Polarean Imaging (POLX ) said its recently resubmitted new drug application (NDA) has now been accepted by the US Food and Drug Administration (“FDA”) as a complete response.
In practice, this means the medical‑imaging technology company can now resume its review process with the US FDA for the company’s hyperpolarised 129Xe drug-combination product which was developed to evaluate pulmonary function and to visualise the lung using MRI.
Today, shareholders of the company were informed that the US FDA had set a user fee goal date – effectively a deadline to assess the new drug application – of 30 September 2022.
Polarean filed for a resubmission of its New Drug Application with the US FDA in March 2022. At the time, shares in Polarean Imaging jumped by over 35% in value following this news.
The filing of the NDA for this combination product, which uses hyperpolarised 129 Xenon gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, follows the receipt of a complete response letter that the company received from the US FDA back in October 2021.
At the time, the Group noted that the issues associated with the delay were mostly “technical or manufacturing-related” in nature and centred around the Xenon hyperpolariser system.
Prior to its resubmission, Polarean confirmed that, following a detailed discussion in the Type A meeting with the US FDA, these issues had been addressed. The Group also said it would make full use of the interim time with regards to commercialisation and launch preparation.
Despite the issues raised by the US FDA, Polarean’s Chief Executive Officer Richard Hullihen told investors at the time that the company remained “confident in the safety and efficacy profile of hyperpolarized noble gas imaging and Polarean’s ability to accomplish its goals.”
As at 30 June 2021, Polarean also held net cash of $38.2m which it said would enable it to fund operations comfortably through the firm’s anticipated response and FDA review periods.
“We are happy that the FDA has accepted our resubmission and look forward to resuming the review process with them in the expanded context of our response,” Hullihen outlined today.
Today, shares in Polarean Imaging were trading 2.73% higher at 56.5p following the news.
View from Vox
Despite an unsuccessful first review cycle with the US FDA, Polarean is now back on track in regard to its commercialisation pathway for the company’s drug-device combination product.
Following a detailed discussion in the Type A meeting with the US FDA in 2021, the company confirmed upon its refiling that the issues spotted by the US regulator – which were identified as mostly “technical or manufacturing-related in nature” had been appropriately addressed.
Meanwhile, the company continues to see the utilisation of its 129Xe MRI technology. In recent weeks, Polarean has received an additional research unit order for a Xenon Polariser system from McMaster University in
Ontario, Canada in order to support the university’s increasing volume of clinical studies, from both academia and drug industry collaborators.
Polarean Imaging is operating in an area of significant unmet medical need, the annual economic burden of pulmonary disease in the US is estimated to be over US $150 billion.
In particular, the company’s combination product is focused on addressing this significant unmet need for our non-invasive, quantitative and cost-effective functional lung imaging.
Follow News & Updates from Polarean Imaging:
