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 Juluca for HIV Therapy
On November 21st, 2017, ViiV Healthcare announced that the US Food and Drug Administration (FDA) has approved Juluca. ViiV Healthcare is a pharmaceutical company specializing in the development of therapies for HIV infection that was created as a joint venture by Pfizer and GlaxoSmithKline in November 2009 with both companies transferring their HIV assets to the new company. Shionogi joined the company in 2012. The ownership structure of ViiV Healthcare is: 76.5% of the company is owned by GlaxoSmithKline, 13.5% by Pfizer and 10% by Shionogi.
Juluca is the first 2-drug regimen composed in one that is indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed. Current antiviral therapy regimens are composed of 3 or 4 different drugs.
One of the drugs in Juluca is dolutegravir, an integrase strand transfer inhibitor (INSTI). The drug is sold by ViiV as Tivicay. It is currently used in combination with other antiretroviral regimens.
The second drug is rilpivirine, a non-nucleoside transcriptase inhibitor (NNRTI. It is sold by Janssen under the name Edurant.
Juluca's 2-drug anti-viral
|Drug Name||Strength, Formulation||Dosing||Tablets per Month||AWP|
|25 mg tablet||1 tablet daily||30 tablets||$1,160.10|
||50 mg tablet||1 tablet daily||30 tablets||$1,842.82|
AWP = average wholesale price. Note that the AWP may not represent the pharmacy acquisition price or the price paid by public and private payors or consumers. Source: http://www.micromedexsolutions.com.
Why is this important?
Current price of antiviral therapy is high and important to consider that patients must take it for the rest of their lives. According to GSK, price tag on Juluca will be $2,579 and according to GSK says is “in the lower range of single tablet regimens used to treat HIV in the U.S.” Other important components of creating new therapy is the advantage of having less side effects associated with medications while achieving same level of efficacy and improved medication adherence with one daily pill.
Abilify MyCite (aripiprazole) is a tablet formulation of the approved and available atypical antipsychotic aripiprazole (brand name Abilify) embedded with an ingestible Proteus® sensor that communicates with a wearable sensor patch and a medical software application to measure adherence in the treatment of adults with schizophrenia, bipolar I disorder, and major depressive disorder.
This type of technology will allow the ability to track patient’s adherence.
The newly approved pill, called Abilify MyCite, is a collaboration between Abilify’s manufacturer, Otsuka, and Proteus Digital Health, a California company that created the sensor. The sensor is ingestible and will transmit a signal to a Band-Aid-like patch that must be worn on the left rib cage when the tablet is dissolved. The sensor, containing copper, magnesium and silicon (safe ingredients found in foods), generates an electrical signal when splashed by stomach fluid, like a potato battery, said Andrew Thompson, Proteus’s president and chief executive. Once that information is received, it will be communicated through a smartphone to track adherence. This data can be shared, upon a signed consent, with the physicians and up to four other people, including family members, to receive electronic information. Information that will be transmitted will include the date and time of pill ingestion. It would also allow to add patient’s mood and resting hours.
It is important to keep in mind that patients will have to agree to take this type of medication and will have the ability to block recipients if they decide to change their mind. Even though, taking this medication is voluntary, privacy could be a concern.
Many patients with schizophrenia, bipolar I disorder, and major depressive disorder that do not take medication regularly that could result in severe consequences.
Why is this important: This is an extremely exciting time that could allow us to increase compliance through use of technology. This is a first sensor-embedded medicine has been approved by FDA. This type of new technology would allow us to collect adherence data. Otsuka has not determined a price for Abilify MyCite, which will be rolled out next year, first to a limited number of health plans. The technology could potentially be used to monitor other conditions such as post-surgical use of opioid medications or a management of a high-risk disease.
- FDA approves pill with sensor that digitally tracks if patients have ingested their medication [news release]. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm. November 13, 2017.
- Abilify MyCite [prescribing information]. Tokyo, Japan: Otsuka Pharmaceutical Co, Ltd; 2017. accessdata.fda.gov/drugsatfda_docs/label/2017/207202lbl.pdf.