Each month, we round up the latest FDA approvals and regulations to give you an expert take on what you need to know.
FDA Approves First-in-Class Leukemia Drug
The FDA approved Tibsovo (ivosidenib) in July for the treatment of relapsed or refractory acute myeloid leukemia (AML) with a certain gene mutation. The majority of AML patients will eventually relapse and treatment options are limited. Of the approximately 20,000 annual new cases of AML, this gene mutation is present in about 10% of those patients.
Given this product, as it is currently approved, has a relatively small patient population, this does have the potential to impact pharmacy budgets. AWP for this oral therapy is approximately $900/day. As with most oncology products, there are ongoing studies in other cancer diagnoses which could influence the impact and utilization of this product on the market.
FDA Approves Nivestym, a biosimilar of Neupogen
NIVESTYM ®(filgrastim-aafi) a biosimilar to Neupogen (filgrastim) has been approved by the FDA for neutropenia associated with chemo therapy as well as the other indications currently held by Neupogen. Neupogen sales in 2017 of just over $500M with most of that spend being on the medical side as its administration is generally coupled with chemotherapy.
Pharmacy budgets will not see much relief as a result of this biosimilar approval, however on a more global scale, this is the third biosimilar approved by the FDA in the last three months. All of the press and focus on biosimilars and drug spend seem to be driving action. Perhaps biosimilars will provide pharmacy cost savings sooner than later. That is still to be determined.
Positive Results From an Alzheimer's Trial
Early results from an Alzheimer’s treatment trial show up to 30% improvement in cognitive testing when compared to placebo. On the surface this is great news with the potential treatment for a condition impacting millions of patients and family members. We shouldn't celebrate just yet.
In initial phase 2 trials, all dosages, except the highest, statistically failed to beat placebo. The tests to measure the cognition of the participants is a proprietary test of the pharmaceutical manufacturer which has not been validated by the FDA. This is not to say that it is better or worse, just another potential hurdle which needs to be addressed by the most recent potential Alzheimer’s treatment.
This is significant as there have been several well-publicized clinical trial failures over the past few years in the Alzheimer’s category. It has been more than 15 years since a new medication received approval to treat Alzheimer’s. When the next product gets approval, it will be a blockbuster overnight and will have a very significant impact on the pharmacy spend. It is estimated that over 5 million people in the United States currently have some form of Alzheimer’s and with the aging population, that number is only going up.