A large Boston-based biotech company is planning to enable participants in its ongoing studies to continue without having to travel to trial sites in order to reduce pressure that the Covid-19 pandemic is expected to place on the healthcare system.
Vertex Pharmaceuticals also said Friday that the pandemic has not had any effect on the supply chain for its approved drugs or its business outlook for this year, adding it has “ample supply” to meet demand “well into the future.” Moreover, its manufacturing plants remain operational, it added.
The company markets several drugs for cystic fibrosis: Kalydeco (ivacaftor), Orkambi (lumafavtor, ivacaftor), Symdeko (tezacaftor, ivacaftor) and Trikafta (elexacaftor, ivacaftor, tezacaftor and ivacaftor). It also has additional drugs in development for CF, pain, alpha-1 antitrypsin deficiency, gene therapies partnered with CRISPR Therapeutics for beta-thalassemia and sickle cell disease and others.
“Despite the widespread impact of the Covid-19 pandemic, the outlook for our business remains unchanged, and we continue to be highly confident in our supply chain and our ability to supply all of our approved medicines to patients who need them,” CEO Jeffrey Leiden said in a statement. “The Covid-19 pandemic is a rapidly evolving global health crisis that will require unprecedented utilization of healthcare resources that we expect will have an impact on our clinical trials.”
The company said that for ongoing clinical trials, it is working with trial sites to enable virtual clinic visits and home delivery of drugs. In other cases, it plans to pause trial enrollment and delay study initiations in order to relieve some of the burden on healthcare systems.
The company’s announcement comes at a time of concern that the pandemic, caused by the novel coronavirus SARS-CoV-2, could threaten pharmaceutical supply chains and cause drug shortages, in particular because of the number of active pharmaceutical ingredients manufactured in China. Meanwhile, numerous companies have announced plans to wind down clinical trial operations – including pausing new enrollments and delaying initiation of new studies – in anticipation of the healthcare system becoming overburdened with treating Covid-19 patients. The FDA has issued a guidance for industry on running trials during the pandemic, as numerous sites have reported that they anticipate disruptions from it.
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