The U.S. Food and Drug Administration has delayed a potentially deadly new drug that could be the first to target the liver and lungs in humans, officials said.
The approval comes as the FDA is struggling to contain the coronavirus pandemic, which has killed more than 17,000 people in the U.K. alone.
But the delay could be a setback for the drug, which is expected to hit the market as early as the end of this year.
The agency said it will continue to work to get approval for the novel drug, known as ALVAR, but only if it is approved as a treatment for the severe coronaviruses.
The agency said in a statement that it has “a very high likelihood” that the drug will be approved.
ALVOR is being developed by Sanofi-Aventis and Novartis Pharmaceuticals, which made the first approved drug for a new coronaviral disease, ALV-20.
But it is unclear when the company will have the product ready to sell.
Alvaro Martinez, president of the National Association of Pharmaceutical Product Regulatory Organizations, which represents the nation’s biggest pharmacy companies, said the delay is a sign of the FDA’s “slow pace in getting approvals for medicines.”
The drug could be used to treat the most severe coronivirus infections, but it is not yet available to the general public.
ALvAR was initially designed to treat patients who had already died, and the drug could also help people who have recovered from the coroniviral disease and are experiencing worsening symptoms.
The FDA said it has been working on a vaccine to treat ALV2, but the agency is not ready to release that drug until it can obtain safety data and other scientific data from the clinical trials.
The FDA is also trying to find the right dosage of ALVARS in order to meet the needs of patients who are too sick to take the drug.
But in the meantime, some doctors and patients are worried about the risk that the treatment will worsen their illness.
The drug is currently available in small, one-dose vials.
Alvars are being tested for possible side effects including dizziness, headache, nausea and vomiting.
The company said its preliminary results show that about 10% of the drug’s users experienced nausea or vomiting while taking the drug for more than six months.
Some people are also reporting that the side effects are worse than expected.
“We are concerned that our patients and physicians are experiencing more severe adverse events with this drug,” Sanofi said in its statement.
“In light of this, we are taking this drug to the full extent of our clinical capabilities to determine whether it will be safe and effective.”
Sanofi said that the company is working with doctors and health systems to ensure that the safety and effectiveness of the medication is well-studied.
The New York-based company is the sole producer of ALvars in the United States.
“The company will work with our partners to ensure the safety of ALVs to patients and our partners in order for us to continue to provide the highest level of care to our patients,” the company said in the statement.
The Sanofi statement did not say what the safety data Sanofi expects from ALvARS.
Sanofi is planning to expand ALVARI vaccines to all patients in the world.
It said that it will offer the vaccine to all the people who are already enrolled in the trial, as well as to people who will enroll next year.
The new vaccines will be available in the coming months.
The U.N. health agency said that some patients are also receiving the drug without having their symptoms worsen.
The United Nations said that at least 15 people have died from the new coroniviruses since the pandemic began in late October.
The U-N said on Thursday that it is urging the world’s health organizations to provide urgent support to patients affected by the coronaviirus.