The Food and Drug Administration has granted Roche a label extension for Evrysdi (risdiplam) to include babies under two months old with spinal muscular atrophy.
SMA is a severe, progressive neuromuscular disease that can be fatal. It affects approximately one in 10,000 babies and is the leading genetic cause of infant mortality. SMA is caused by a mutation of the survival motor neuron 1 gene, which leads to a deficiency of SMN protein. This protein is found throughout the body and is essential to the function of nerves that control muscles and movement. Without it, nerve cells cannot function correctly, leading to muscle weakness over time. Depending on the type of SMA, an individual’s physical strength and their ability to walk, eat or breathe can be significantly diminished or lost.
“The approval of Evrysdi for pre-symptomatic babies is particularly important, as early treatment of SMA, before symptoms start to arise, can help babies to achieve motor milestones,” said Richard Finkel, Rainbowfish principal investigator and director of the Experimental Neuroscience Program at St. Jude Children’s Research Hospital. “With the inclusion of SMA in newborn screening programs, this approval provides the opportunity to start treating at home with Evrysdi soon after the diagnosis is confirmed.”
“The priority review and subsequent approval of Evrysdi for babies under two months of age speaks to the urgent ongoing need for additional treatment options for babies with SMA,” said Levi Garraway, Roche’s chief medical officer and head of global product development. “Because of its efficacy in multiple settings, Evrysdi is now available for people with SMA from pre-symptomatic newborns to older adults. We are proud of this achievement, which has the potential to make a real difference to those living with SMA and their caregivers.”
Evrysdi is a survival motor neuron 2 splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.
Accord is offering pemetrexed lyo. injection, a new product in its line of chemotherapy drugs.
The drug is formulated as a sterile lyophilized (freeze-dried) powder to be reconstituted for intravenous infusion. Pemetrexelyo. injection is the generic of Eli Lilly’s Alimta.
It is used to treat non-squamous non-small cell lung cancer and malignant pleural mesothelioma, a cancer of the inside lining of the chest cavity.
Accord's generic product is offered in vials of 100-mg, 500-mg and 1,000-mg strengths, and is currently available to ship.
Pemetrexed lyo. injection is FDA approved for use as a first-line treatment for locally advanced or metastatic NSCLC with non-squamous tissue type, a maintenance drug for metastatic NSCLC, a treatment for NSCLC that recurs after prior chemotherapy and a treatment for MPM in patients whose cancer can't be removed surgically.
"Accord Healthcare US has distinguished itself in oncology injectables, and the introduction of pemetrexed lyo. injection to our portfolio strengthens our offering of oncology medications," said Accord CEO Jeff Hampton. "We are committed to making more generics available to patients. Our technical capabilities and manufacturing infrastructure have defined our company's history and the patients shape our future."
Alimta is approved in combination with Keytruda (pembrolizumab) immunotherapy and platinum chemotherapy (carboplatin or cisplatin, two other chemotherapy drugs) as the first treatment for nonsquamous non-small cell lung cancer that has spread with no abnormal EGFR or ALK genes.
The medication is the generic of Eli Lilly’s Alimta (pemetrexed for injection).
The Alimta brand and generic had a market value of approximately $1.2 billion for the most recent 12 months ending in March 2022, according to IQVIA.
Dr. Reddy’s pemetrexed for injection is supplied in 100 mg and 500 mg single-dose vials.
Bazooka Candy Brands is disrupting the confectionary space with a brand-new gummy innovation.
Push Pop Gummy Pop-its feature gummies that are coupled with an interactive and refillable container that makes the experience a treat from start to finish, the company said.
Available in an assortment of flavors — strawberry, blue raspberry, berry blast and watermelon — to enjoy the treats consumers simply need to flip open the container lid, pull it up and push back down to reveal a soft and airy gummy.
“Push Pop Gummy Pop-its is a true example of our company mission at Bazooka Candy Brands to keep bringing edible entertainment to new levels,” says Becky Silberfarb, vice president of brand marketing for the Americas. “More than just a differentiated gummy product in a fast-growing category, Push Pop Gummy Pop-its delivers just what our fans love — a really unique and fun new eating experience.”
Amneal obtains FDA green light for Neulasta biosimilar
Amneal has received the Food and Drug Administration’s blessing for pegfilgrastim-pbbk, a biosimilar of Amgen's Neulasta.
The product, developed in collaboration with Kashiv Biosciences, will be marketed under the proprietary name Fylnetra.
The medication is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection), which is commonly experienced by patients undergoing chemotherapy.
This marks the third biosimilar approval Amneal received this year for products used in oncology, the second-largest biosimilar category in the United States. Earlier this year, Amneal received approval of Releuko (filgrastim-ayow), a filgrastim biosimilar of Neupogen, and Alymsys (bevacizumab-maly), a bevacizumab biosimilar of Avastin.
“This is our third U.S. biosimilar approval this year and we are very enthusiastic about our future in the fast growing $28 billion U.S. biosimilars market,” said Chirag and Chintu Patel, co-CEOs. “Biosimilars represent the next wave of affordable medicines and are closely aligned with our mission to provide high quality, affordable medicines to as many patients as possible.”
In addition, the company said that it expects to launch these three products over the second half of 2022, along with a full patient support program.
“Building on our successful partnership with the recent approval of our first biosimilar, Releuko, we are pleased to receive approval for our second biosimilar. Kashiv is one of a few domestic companies to manufacture and launch multiple biosimilars in the United States. Kashiv aims to continue bringing high quality biosimilars to the global markets over the coming years,” said Chandramauli Rawal, CEO of Kashiv. “I would like to extend a humble thank you to our highly talented team, without whom this would not have been possible.”
Pegfilgrastim had a market value of $3.1 billion, $1 billion of which represented biosimilar sales, for the 12 months ending March 2022, according to IQVIA.
Perrigo’s Omeprazole Magnesium mini capsules given FDA approval
Perrigo announced that it has received final approval from the U.S. Food and Drug Administration for its Omeprazole Magnesium Delayed-Release Mini Capsules in 20 mg for over-the-counter availability.
The launch represents the first to market mini capsule form of omeprazole, which is indicated for the treatment of frequent heartburn and is 70% smaller than the tablet version currently available, the company said.
“This approval illustrates Perrigo’s research and development, and regulatory expertise, and our continued focus on product innovation to provide value for both our customers and consumers,” Perrigo executive vice president and president of consumer self-care Americas Jim Dillard said. “The omeprazole mini product exemplifies our national brand different strategy and provides our store brand partners with a differentiated product in the marketplace.”
The product will be marketed under the retailer’s store brand labels comparable to Prilosec OTC.