Product
Edurant
Approval Date
May 20, 2011
Company
Janssen Therapeutics (formerly Tibotec)
Class
Non-nucleoside reverse transcriptase inhibitor
Indication
For use in combination with other antiretroviral agents (ARVs) in the treatment of human immunodeficiency virus type 1 (HIV-1) in adults who have never taken HIV therapy (treatment naïve).
Active Ingredient
Rilpivirine
Agency Roster
ICC Lowe (general promotion)
ICC Lowe Thermal (digital)
Marketing Strategy/Execution
The field force for Janssen Therapeutics, formerly known as Tibotec Therapeutics, is using interactive tactics to detail new anti-HIV medication Edurant to physicians. Launch materials include deployment of Motorola Xoom tablet. Other introductory tactics include an HCP website, leave-behind materials and supporting introductory letters. Interestingly, the research leading up to approval of Edurant, previously known as TMC278, was championed by none other than Dr. Paul Janssen, who founded one of Johnson & Johnson’s first pharmaceutical companies more than 50 years ago.
Physician Outlook
Edurant (rilpivirine) from Tibotec Therapeutics, a division of Centecor Ortho Biotech, is a new Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) approved by the FDA in May 2011 for HIV-1 infected patients naïve to antiretroviral therapy. Many physicians are excited to have this new once-daily NNRTI option that demonstrated a lower incidence of patient withdrawal from trials due to CNS side effects than the current once-daily NNRTI, Sustiva (efavirenz). However, physician enthusiasm for Edurant is somewhat tempered by less demonstrated efficacy in patients with viral loads above 100,000 copies. Edurant is also associated with more viral rebound and drug resistance in patients who failed Edurant. These considerations have some physicians planning to choose patients with lower baseline viral loads and/or history of CNS-related comorbidities such as depression as likely candidates for Edurant-based combination therapy.
-Will Leskin, Senior Vice President, Research and Consulting, GfK HealthCare
Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: Kivexa
Manufacturer:GlaxoSmithKline
Indication: HIV infections
Active ingredient: Abacavir
Phase: III
Drug: ‘572
Manufacturer:ViiV Healthcare
Indication: HIV infections
Active ingredient: Dolutegravir
Phase: IIIDrug: Elvitegravir
Manufacturer:Gilead Sciences
Indication: HIV infections
Active ingredient: Elvitegravir
Phase: III
Source: Wolters Kluwer Pharma Solutions
Pharmacology
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Clinical Trials
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adverse Reactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adults
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Children
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Precautions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Interactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
