Cobicistat/Darunavir

The fixed-dose combination of PREZCOBIX/REZOLSTA is a collaborative effort between Janssen R&D Ireland and Gilead. Credit: Dmytro Zinkevych/ Shutterstock. Johnson & Johnson (J&J) has filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking expanded approval for the use of its HIV-1 therapy, PREZCOBIX  (darunavir/cobicistat), in children aged six years and above. Recommended Buyer's Guides Buyer's Guide Leading Guide to Compliance Software for the Pharmaceutical Industry Buyer's Guide Top Guide for Drug Delivery Systems Approval is being sought for PREZCOBIX use in paediatric patients weighing a minimum of 25kg. In Europe, the company has submitted applications to the European Medicines Agency for the paediatric use of the medication, marketed as REZOLSTA. Approval of the applications would enable PREZCOBIX/REZOLSTA to be administered to both adults and paediatric patients from the age of six years. A new paediatric formulation has been developed, featuring a lower dose tablet (darunavir 675mg/cobicistat 150mg) making it easier for children to swallow. See Also: The tiny pills that may send shockwaves across immunology Roche’s PI3K inhibitor secures breakthrough status in breast cancer The applications are supported by data from a clinical study, sponsored by Janssen Research & Development (R&D), which indicated that the new combination tablet is bioequivalent to the individual doses of darunavir and cobicistat. A Phase II/III clinical trial by Gilead Sciences has established the efficacy, safety and tolerability of cobicistat-boosted darunavir in treating younger children with HIV-1. PREZCOBIX/REZOLSTA combines darunavir, an HIV-1 protease inhibitor, with cobicistat, a CYP3A inhibitor that enhances the pharmacokinetics of the therapy, allowing for once-a-day dosing. The therapy is currently approved for use in adults and adolescents weighing a minimum of 40kg without resistance mutations to darunavir. Darunavir is marketed by Janssen Products as PREZISTA in the US, and cobicistat, developed by Gilead Sciences, is sold as TYBOST. The fixed-dose combination of PREZCOBIX/REZOLSTA is a collaborative effort between Janssen R&D Ireland and Gilead. Johnson & Johnson infectious diseases and vaccines and global public health R&D global therapeutic area head Penny Heaton stated: “We are proud of this latest step in our years of work to ensure that some of the youngest people living with HIV have access to different treatment regimens that can work for them. “If approved, this medicine could offer healthcare providers a new treatment option that ensures weight-appropriate dosing to better meet the needs of young people living with HIV.” The latest development comes after Johnson & Johnson gained the global rights to Numab Therapeutics’ investigational first-in-class antibody, NM26 for atopic dermatitis.

Headline results for the second quarter: Prescription drug sales: $13.7 billion, up 3.1% Overall revenue: $25.5 billion (forecasts of $24.6 billion), up 6.3% Profit: $5.1 billion, up 6.9%Note: All changes are versus the prior-year period unless otherwise statedWhat the company said:Johnson & Johnson noted that growth in the second quarter was driven by Darzalex, Carvykti, Stelara, Tremfya, Uptravi, Opsumit and Spravato, which was partially offset by Zytiga, Imbruvica, COVID-19 vaccines and Remicade.CEO Joaquin Duato, who has been in the job for just over a year, said "we are entering the back half of the year from a position of strength with numerous catalysts, including becoming a two-sector company focused on pharmaceutical and medtech innovation."Other quarterly results: Immunology product sales: $4.5 billion, up 1.9% Stelara: $2.8 billion, up 7.6% Tremfya: $706 million, up 18.3% Remicade: $462 million, down 28.6%, hit by biosimilar competition Oncology product sales: $4.4 billion, up 8.8% Darzalex: $2.4 billion, up 22.4% Imbruvica: $841 million, down 13.2%, due to "global competitive pressure" Erleada: $567 million, up 25.9% Zytiga: $227 million, down 55.1%, following loss of exclusivity Carvykti: $117 million, up from $24 million in the prior year Infectious diseases product sales: $1.1 billion, down 14.8% COVID-19 vaccine: $285 million, down 47.7% Prezista/Prezcobix/Rezolsta/Symtuza: $491 million, up 5.8% Invega Sustenna/Xeplion/Invega Trinza/Trevicta: $1 billion, down 2.1% Pulmonary hypertension products: $972 million, up 15.3% Xarelto: $637 million, up 4.7% Consumer health: $4 billion, up 5.4%, which was recently split off into a standalone company called KenvueLooking ahead:Johnson & Johnson now expects sales this year of between $98.8 billion and $99.8 billion, with both ends lifted by $900 million from the guidance issued in April. The company added that it sees "slightly higher" operational sales growth in the second half of the year for prescription drugs.Meanwhile, earnings in 2023 are predicted to be from $10.70 to $10.80 per share, with both ends of the range increased by $0.10 from an earlier estimate. above estimates of $10.65 per share