US-FDA has approved Eli Lilly and Company's new ultra rapid-acting insulin Lyumjev™ (Insulin lispro-aabc injection) for type 1 and type 2 diabetes.


 The US FDA granted approval to Eli Lilly’s Lyumjev™ (insulin lispro-aabc injection, 100 units/mL and 200 units/mL). This is a new rapid fast-acting insulin with a novel formulation to speed up the absorption of insulin into the blood stream and reduce glucose levels post meals, mimicking natural insulin’s post prandial action. Eli Lilly has another fast-acting insulin Humalog™ in the market. In comparative studies, Lyumjev™ has demonstrated faster absorption profile compared to Humalog™. The rapid insulin time-action profile can be attributed to two excipients in the formulation: microdose of treprostinil which increases absorption through vasodilation and sodium citrate which increases local vascular permeability.

The approval of the drug was based on two phase 3 studies: PRONTO T1D and PRONTO T2D. In both studies Lyumjev™ demonstrated superior action compared to Humalog in preventing blood glucose spikes one and two hours after meal. Earlier this year, the product was approved by EMA in Europe and PMDA in Japan.

The newly approved drug will be part of Lilly Insulin Value Program which enables patient access to the product with or without insurance at a maximum cap of $35 for their monthly dose. This is a welcome move at a time when insulin affordability could become more challenging for patients in the USA, many of whom have been living on a shoestring due to the pandemic.

USA has just one other fast-acting insulin lispro Admelog™ from Sanofi, Humalog™, and now Lyumjev™ by Eli Lilly. Regulatory agility in addressing affordability barriers for patients with diabetes is very encouraging – with the FDA having a new system in place for insulin products to be approved as a biologic, opening avenues for more developers to come up with ‘generic’ versions of insulin. The product is directly classified as a biologic now, approved under the 351(a) pathway, becoming one of the first few products being approved under FDA’s new regulatory system for insulin products. The most recent product to be approved under the new system was Biocon and Mylan’s samglee

Comments

Post a Comment

Popular posts from this blog

Gas Leak at Maharashtra Chemical Factory, Residents Complain of Breathing Problems

Image
  The accident occurred at a factory called Nobel Intermediates Pvt in Shirgaon MIDC's Aptewadi area around 10:22 p.m.   A gas leak on Thursday night, from a chemical factory in Maharashtra's Badlapur, was reported, causing panic among the locals. Several residents within three kilometers complained about difficulty breathing and eye irritation.   A few people were admitted to local hospitals as a precaution. They were discharged after seeking medical assistance. The fire brigade hurried to the plant as soon as the incident was reported and controlled the situation. The leakage was stopped at about 11:24 p.m. The officials said that no casualties were reported.  According to the Thane Municipal Corporation, the incident occurred due to a chemical reaction caused by the overheating of sulfuric acid and benzyl acid. The police warned locals to stay indoors for a couple of hours.  The situation, according to officials, is under control now. 
Read more

How Delta variant of COVID 19 is causing disaster across the world

Image
 A recent study by All India Institute of Medical Science (AIIMS) claimed that the presence of Delta variant is predominantly found even after getting a single dose or both doses of Covid-19 vaccine. According to some experts, both doses of the Covid-19 vaccines are needed for strong protection against the Delta variant. A highly transmissible variant of the coronavirus disease (Covid-19) is now rapidly spreading across the globe, causing more stringent control in some countries and derailing lockdown plans of others. The Delta variant, first detected in India, has been listed as 'variant of concern' by the World Health Organization (WHO). Here's how the Delta variant is affecting the world: The Zimbabwean government on Saturday announced a two-week localised lockdown for Hurungwe and Kariba districts after detecting the Delta variant of Covid-19. The government said that more than 40 cases were recorded in the last three days. The UK government is considering a delay of up...
Read more