What we know about the FDA’s decision to ban a new type of blood-thinning drug for cancer patients
The U.S. Food and Drug Administration (FDA) on Thursday banned a new blood- thinning drug from generic manufacturers.
The drug, Focussed, was developed by Johnson & Johnson and is being made by Roche in the United Kingdom.
The FDA said it was based on evidence from clinical trials of Focured and its sister drug, Directrix.
The new drug will be on the market from the start of 2018.
The decision comes amid concerns about the safety of Fosigen, a new drug that is designed to slow the rate of a rare genetic disorder that kills more than a million Americans every year.
The company, which was also making the drug, said in a statement it was disappointed the FDA had “reached a different conclusion than the FDA previously did.”
Focused is the only generic drug approved by the FDA to treat the genetic disorder, and Roche is the sole manufacturer.
The drugs are intended to be used by people who already have a gene mutation in a gene that causes them to lose some or all of their blood.
It’s not clear whether the new drug is safe.
In September, Roche said the drug had been shown to work against three different kinds of the gene mutation, but the FDA said that analysis did not demonstrate the drug’s safety.
It was not immediately clear if the company would appeal the FDA decision.
A U.K.-based company, AstraZeneca, also recently won approval for a new generic version of Fucosine, a drug designed to treat a rare type of rare cancer called Duchenne muscular dystrophy.
The companies have yet to disclose how the drugs will be made, but it’s not known whether they’ll be based on Focuss or Directrix, which have not yet been approved by regulators.
Astra and Roche said in statements that the companies have “a long history of collaboration and collaboration is a core value of Roche.”
Fosogen, which is still being tested, is the first drug approved for Duchennes in the U..
S., and Roche has been working on a second drug.
The American Cancer Society, which opposes the FDA approval of Folsom, said the new decision would have a “significant impact” on Duchennea patients.
The organization also called on the FDA and drug makers to “review the scientific evidence and data supporting their product candidates.”
The American Academy of Pediatrics and other pediatricians are also calling on the agency to reconsider its decision.
The group said Fosogene and Directrix have been approved for use in children who have certain genetic mutations that cause them to grow faster, have lower rates of cancer and have a higher chance of survival.
Doctors, pediatricians and others have raised concerns about Fosagen and Directrices safety.
They also have expressed concerns about potential side effects in children, such as bleeding and heart problems.
In its ruling, the FDA also said it is reviewing Fosogens data to determine whether the drug is effective for treating Duchennias and whether it can be used in the future.
“Fosogen has received widespread attention from researchers, doctors, and patients,” FDA Commissioner Dr. Nancy Wu said in the statement.
“This decision will help ensure that we can move forward with Fosogens development as quickly as possible.”