Pill Instead of a Needle May Soon Be Option for RA
Studies Show a New Kind of Drug Works at Least as Well as a Current RA Biologic and Is Effective as a Stand-Alone Treatment
The Research continued...
Having a broader action sometimes makes a medication very powerful, but it can also increase the drug's potential for side effects since it affects more processes that take place downstream.
In the current studies, common side effects included upper respiratory tract infection, headache, and diarrhea. Tofacitinib was also linked to reduced white blood cell counts. White blood cells help the body fight infections.
And, patients taking the drug were more prone to viral and bacterial infections. Two patients on the highest doses of it developed tuberculosis.
Patients taking tofacitinib also had increased levels of LDL, the "bad" cholesterol. That's concerning since having RA roughly doubles a person's risk for heart disease.
"We don't know what it means if your cholesterol goes up a lot but inflammation goes down. Is that bad for the heart or the brain? Is it neutral? Is it good? We don't know," Curtis tells WebMD.
While those side effects are concerning, many other drugs that are already approved for RA have similar risks, Curtis says.
From Lab to Pharmacy
In May, a panel of advisors voted that despite the risks, the FDA should approve the drug. The agency was set to make its decision on the drug this month. But last week, the drug's manufacturer, Pfizer, announced that regulators had asked for more information and said they expected that the FDA's decision to be delayed.
Pfizer has not revealed how it will price the drug if approved, but it is expected to be expensive. The company said in a statement that it is committed to helping patients get access to the medication should it become commercially available.
If approved, tofacitinib is expected to be a blockbuster, generating sales of more than $1 billion a year, according to EvaluatePharma.
How much money it makes will depend on how doctors use it. Much of that will ride on the labeling the FDA might require. The agency could say that it should only be used in combination with methotrexate, for example. Or it could say that it should only be prescribed after other medications have failed.