First Drug For Kids With Peanut Allergies Approved By FDA, But Some Say It’s Cumbersome And Carries Safety Risks
Aimmune Therapeutics believes its treatment, Palforzia, could deliver annual sales exceeding $1 billion. But critics say Palforzia is more likely to be a niche treatment given its tolerability and side effect issues, which include higher rates of gastrointestinal problems and allergic reactions.
The Associated Press:
FDA Approves First Treatment For Kids With Peanut Allergy
The first treatment for peanut allergies is about to hit the market, a big step toward better care for all kinds of food allergies -- but still a long way from a cure. Friday’s approval by the Food and Drug Administration promises to bring some relief to families who’ve lived in fear of an accidental bite of peanuts at birthday parties and play dates, school cafeterias and restaurants. Named Palforzia, it was developed by Aimmune Therapeutics. (Neergaard, 1/31)
The Washington Post:
Peanut Allergy Drug Palforzia Is The First To Be FDA Approved
The therapy, Palforzia, isn’t a cure and comes with significant risks of triggering the very reactions it is supposed to quell. But for families and children who have re-engineered their routines to minimize potential exposures — changing how and whether they travel, eat out, socialize and feel safe in their daily lives — it could offer an important layer of protection and relief. Palforzia is seen as an important test case for a new generation of therapies expected to transform how food allergies are treated. Doctors who have had few tools other than counseling their patients to assiduously avoid peanuts expect that other drugs will follow — additional drugs for the peanut allergy, as well as egg and tree nut allergies. Aimmune Therapeutics, which makes Palforzia, has several other food allergy treatments in its pipeline. (Johnson, 1/31)
The Wall Street Journal:
FDA Approves First Drug For Peanut Allergy
To build up their resistance, children ages 4 to 17 years who are prescribed the new therapy start with escalating doses of Palforzia mixed with apple sauce or other food each day, and after reaching a certain dose continue on that dose indefinitely. Aimmune said the list price for Palforzia will be $890 a month, or about $10,680 a year. Roth Capital Research analyst Zegbeh Jallah estimates the drug could generate annual sales of $1 billion by 2026. (Loftus, 1/31)
CNN:
FDA Approves First Drug To Treat Peanut Allergies In Children
More than 2.5% of all American children are allergic to peanuts, according to The American College of Allergy, Asthma and Immunology. It's one of the most common food allergies in the country. For those allergic, exposure to peanuts can result in symptoms like cramping, indigestion, hives, swelling and even fainting or dizziness. (Asmelash, Christensen and Kounang, 2/3)
Stat:
Commercial Success Of First Peanut Allergy Treatment Is Not Assured
Children and teenagers with severe, sometimes life-threatening peanut allergies can reduce their risk from accidental exposure with a new treatment approved Friday by the Food and Drug Administration. But administering the new treatment, called Palforzia and made by Aimmune Therapeutics (AIMT), is cumbersome and carries its own safety risks, which may deter families and allergists from using it. Palforzia’s approval was widely expected given the endorsement last September from an FDA advisory panel. The success of the product’s commercial launch is more uncertain but will be closely followed throughout 2020. (Feuerstein, 2/3)
In other pharmaceutical news —
Stat:
Employers Shoulder Plenty Of Drug Costs, But Haven’t Lobbied Much To Lower Them — Until Now
The new group called EmployersRx, a joint project of the National Alliance of Healthcare Purchaser Coalitions, the Pacific Business Group on Health, the ERISA Industry Committee, and the Silicon Valley Employers Forum, is hoping to push lawmakers to start thinking about drug pricing policies that will affect the broadest number of Americans, not just changes to federal programs.And it’s going further than you’d expect: it’s “intrigued by” the progressive package of reforms being pushed by Speaker Nancy Pelosi, in part because the current version would give employers the chance to buy drugs at prices that Medicare had negotiated. The group hasn’t formally endorsed the bill, but its coy position on it is a startling departure from the rest of the business community, which has blasted the bill as socialist and bad for business. (Florko, 2/3)
