The COVID-19 pandemic continues to impact the pharmaceutical and life sciences industries, with the latest to be affected being US-based biotech company bluebird bio.
In an update on its business operations and clinical programme development released yesterday, bluebird bio said that it expects the pandemic to delay the timing of enrolment and completion of clinical studies by at least three months, although this will likely vary between each trial and programme.
That delays also include its application to the US Food and Drug Administration (FDA) for its gene therapy for beta thalassemia LentiGlobin – which has already been approved in Europe with the brand name Zytneglo.
Bluebird has already faced a number of delays to the completion of its FDA submission for the gene therapy, after the biotech previously failed to reach an agreement with the regulatory agency after the FDA asked for additional data for the review.
Prior to the coronavirus outbreak, bluebird had been hoping to complete the filing for LentiGlobin within the first half of the year, but that was pushed back to the second half of the year last month after the FDA asked for further additional information.
Due to the multiple delays and pushbacks from the FDA, as well as the inevitable impact of the pandemic on the FDA’s normal operations, the application is likely to be pushed back even further.
In Europe, where LentiGlobin is already approved as Zynteglo, the biotech also expects delays to its commercial launch thanks to the COVID-19 outbreak.
Earlier this year, bluebird announced that the gene therapy was available in Germany, its first market – while the preparation of patients for treatment in the country is ongoing, the first commercial patient to actually receive the treatment is likely to be shifted to the second half of the year.
Germany is currently fighting against its own outbreak of COVID-19, with over 47,000 confirmed cases as of 27 March – although its death rate is relatively low compared to other countries.
Meanwhile, on the clinical trial front, bluebird’s ongoing studies for LentiGlobin are currently remaining active, although disruption to study conduct is expected.
It has, however, suspended enrolment for its Bristol-Myers Squibb-partnered studies for ide-cel, which includes the KarMMa-2, KarMMa-3 and KarMMa-4 studies.
“The COVID-19 pandemic has created new challenges for bluebird, the broader biotech community, and society as a whole. During this unprecedented time, we remain focused on caring for the patients who rely on us,” said Nick Leschly, chief executive officer of bluebird.
“In addition, we are prioritising the safety and well-being of our employees, making a positive impact as a member of our local community, and continuing to execute on our business strategy,” he added.