Lupin receives FDA nod for generic Plaquenil tablets
Lupin has received the green light from the Food and Drug Administration for a generic version of Concordia Pharmaceuticals’ Plaquenil tablets, 200 mg. (hydroxychloroquine sulfate tablets, 200 mg).
The product is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale and P. vivax; the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported; the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and the treatment of acute and chronic rheumatoid arthritis in adults.
The product’s market size for the 12 months ended April 2018 was $215.3 million, according to IQVIA data.
Mylan expands central nervous system portfolio with generic Exelon patch
Mylan has received the green light from the Food and Drug Administration for a generic version of Novartis’ Exelon Patch (rivastigmine transdermal system). The product is indicated for the treatment of dementia associated with mild, moderate and severe Alzheimer’s disease and the treatment of mild-to-moderate dementia associated with Parkinson’s disease.
The generic Exelon patch is available in 4.6 mg/24 hrs, 9.5 mg/24 hrs and 13.3 mg/24 hrs.
“The launch of generic Exelon Patch is another example of the investment Mylan is continuing to make into products that are difficult to develop and manufacture, particularly in transdermal drug delivery systems. The launch of this product also strengthens the company’s growing central nervous system portfolio, which is a therapeutic area of continued focus for Mylan as we strive to provide better health for a better world,” said Mylan president Rajiv Malik.
Inovio’s MERS vaccine yields positive results in Phase 1 study
Inovio Pharmaceuticals announced positive phase 1 results of its collaborative vaccine study with INO-4700 (GLS-5300) against the Middle East respiratory syndrome, or MERS.
Results for INO-4700, which is being co-developed by Inovio and GeneOne Life Science showed that the drug was well-tolerated and demonstrated overall high levels of antibody responses in roughly 95% of subjects, while also generating broad-based T cell responses in nearly 90% of study participants.
The phase 1, open-label, dose-escalation MERS vaccine trial, in partnership with the Walter Reed Army Institute of Research in Maryland, displayed antibody responses by ELISA in 94% of subjects at week 14 — two weeks post-third dose. Additionally, there were no statistically significant dose-dependent differences in antibody response rates — 91%, 95%, and 95% at doses of 0.67, 2, and 6 mg, respectively. Durable antibody responses to INO-4700 were also maintained through 60 weeks following dosing.
“Inovio is utilizing our versatile immunotherapy and vaccine platform to target and develop the most advanced preventive vaccine for MERS, a virulent viral infection with no medical countermeasure. This trial further demonstrates Inovio’s commitment to fighting emerging viral threats, while also continuing to validate consistent high levels of both immune and antibody responses across our infectious disease platform. We look forward to continuing this development in a partnership with GeneOne and CEPI for developing novel therapies for MERS,” Inovio president and CEO Dr. J. Joseph Kim said.