Lupin intros generic Temovate ointment
Lupin is launching its generic Temovate (clobetasol propionate ointment 0.05%). The product was previously approved by the Food and Drug Administration.
The product is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Clobetasol propionate ointment 0.05% had a market value of approximately $93.4 million, according to June 2018 IQVIA data.
Leadiant Bioscience gets FDA green light for Revcovi
Leadiant Bioscience has received the Food and Drug Administration’s blessing for Revcovi (elapegademase-lvlr) injection.
Revcovi is a new enzyme replacement therapy for the treatment of adenosine deaminase severe combined immune deficiency, or ADA-SCID, in pediatric and adult patients.
“We are gratified by the FDA’s timely recognition of Revcovi as an effective and safe treatment for ADA-SCID, which, in addition to being ultrarare, is one of the most devastating genetic disorders,” Leadiant Biosciences CEO Michael Minarich said in a statement. “We extend our deepest gratitude to the patients who participated in the clinical trials and their families and caregivers who supported them. We also appreciate the hard work of the investigators, clinicians and study staff to bring this therapy to patients in need. We look forward to continuing to work together to serve the ADA-SCID community.”
Revcovi is a PEGylated recombinant adenosine deaminase enzyme used to treat ADA-SCID. The product of recombinant technology, Revcovi eliminates the need to source the enzyme from animals and works by supplementing levels of an essential enzyme called adenosine deaminase, or ADA.
ADA-SCID is an ultrarare, inherited genetic disorder, caused by a deficiency in the ADA enzyme that is fatal if left untreated. Patients affected by ADA-SCID have compromised immune systems that leave them unprotected from infection-producing bacteria, viruses and fungi. ADA-SCID primarily affects infants and young children. The disease is typically diagnosed within the first few months of life. Undiagnosed babies with ADA-SCID usually die before they reach the age of two due to infections. SCID newborn screening in most states has allowed detection of ADA-SCID in newborns and has led to early initiation of ADA enzyme therapy and improved outcomes.
The FDA granted this application Fast Track and Priority Review. Revcovi also received Orphan Drug designation.
FDA approves Roche’s Hemlibra for hemophilia A without factor VIII inhibitors
Roche has received clearance from the Food and Drug Administration for Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A without factor VIII inhibitors.
Hemlibra is now the only prophylactic treatment for people with hemophilia A with and without factor VIII inhibitors that can be administered subcutaneously, under the skin, and at multiple dosing options — once weekly, every two weeks or every four weeks — the company said.
“Many preventative treatment options for people with hemophilia A without factor VIII inhibitors require intravenous infusions several times a week. Even then, people can still experience bleeds, and there has been a need for more treatment options,”Michael Callaghan, Children’s Hospital of Michigan and Detroit hematologist said in a statement. “The approval of Hemlibra is an important advancement for the entire hemophilia A community, as we now have a new class of medicine for the first time in nearly 20 years. Hemlibra can reduce bleeds, and it offers a new subcutaneous administration once weekly, every two weeks or every four weeks.”
“Today’s approval of Hemlibra reflects our commitment to groundbreaking science and the development of medicines with the potential to redefine the standard of care,” Roche’s chief medical officer and head of global product development Sandra Horning said in a statement. “Hemlibra is now the only FDA-approved medicine for people with hemophilia A with and without factor VIII inhibitors, based on the efficacy and safety profile demonstrated across four pivotal studies. We want to thank the hemophilia community for their partnership in helping us bring this new option to everyone living with hemophilia A.”
Hemlibra was granted Breakthrough Therapy Designation by the FDA for hemophilia A without factor VIII inhibitors. It also was granted Priority Review, a designation given to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease.