Each month, we round up the latest FDA approvals and regulations to give you an expert take on what you need to know.
Glenmark Pharmaceuticals Gets Approval on Generic Option for Multiple Sclerosis
A generic formulation of Aubagio (teriflunomide) was approved by the Food and Drug Administration in November. The manufacturer, Glenmark Pharmaceuticals, will have 180 day exclusivity period for both the 7mg and 14mg strengths. 1 With the exclusivity period, there will likely not be significant savings for at least 6 months, however considering annual sales are approximately $1.6 billion1, there will likely be additional entries into this space shortly after the exclusivity period ends.
New Recommendation in HIV
This November, the United States Preventative Services Task Force (USPSTF) came out with new draft recommendations for persons at high risk for HIV acquisition.2
The document recommends pre-exposure prophylaxis for individuals who are at high risk of HIV acquisition. This will increase the utilization of Truvada (emtricitabine/tenofovir disoproxil fumarate) due to its current FDA approved indication for pre-exposure prophylaxis of HIV.
The cost per month of therapy is upwards of $1,700,2 therefore these updated recommendations may result in significant pharmacy cost increases. It is important to note that these recommendations are in the draft stage and have not been finalized. However, it is very likely the final recommendations will be similar to the draft version.
FDA Approves New Cancer Medication
The headline may not be that unique considering the pharmaceutical pipeline has been focusing on oncology products for quite some time. What is unique is the indication for this product. Vitrakvi (larotrectinib) is indicated for cancers with a single rare genetic mutation.1 This mutation was found in several different types of cancers including lung, pancreatic, breast, colon among others.
Unlike most oncology products which are indicated for certain cancers based on location within the body, Vitrakvi is for solid tumors with certain genetic regardless of location. Vitrakvi is an oral therapy which joins Keytruda (pembrolizumab injection)2 as products approved for cancers with certain biomarkers instead of location. All of the hype we've on ground-breaking scientific advances are starting to become reality.