MannKind Shares Jump 5% After FDA Approves $35/Month Afrezza for Children 6+
MNKD•MannKind shares surged 5% after FDA approved Afrezza for children aged 6+ with type 1 or type 2 diabetes, making it the only ultra-rapid inhaled mealtime insulin for pediatric patients. Eligible users can access Afrezza at a monthly cost of $35 or less, backed by Phase 3 INHALE-1 data.
1. FDA Approval Overview
MannKind received FDA approval to expand Afrezza use to children aged 6 and older with type 1 or type 2 diabetes, becoming the only ultra-rapid inhaled mealtime insulin option for pediatric patients and triggering a 5% share increase.
2. Phase 3 INHALE-1 Trial Results
The Phase 3 INHALE-1 trial enrolled 230 participants aged 4–17 and met its primary endpoint of HbA1c noninferiority versus rapid-acting injections, while demonstrating higher patient satisfaction and reduced weight gain in the inhaled insulin cohort.
3. Market Implications and Pricing
Eligible pediatric patients can begin accessing Afrezza immediately at a cost of $35 or less per month, offering a needle-free alternative to multiple daily injections or pump therapy and potentially unlocking new revenue streams.
4. Technosphere Delivery Technology
Afrezza’s proprietary Technosphere technology delivers insulin powder to the deep lung, with blood levels peaking in 35–45 minutes and mimicking natural mealtime insulin response without the need for needles.
