Post by lakers on Oct 5, 2017 20:53:40 GMT -5
Danbury Times: FDA approves new label language for Afrezza
By Chris Bosak Published 3:45 pm, Tuesday, October 3, 2017
www.newstimes.com/business/article/FDA-approves-new-label-language-for-Afrezza-12250087.php
MannKind received FDA approval to update the label on its inhalable insulin product, Afrezza, in a move that will make it easier to market the drug, the company announced this week.
The new label will clarify the starting and mealtime dosages, in addition to listing the initial and peak effects of the drug.
“It’s a pivotal moment in the history of the company,” CEO Michael Castagna said during a conference call on Monday. He said the labeling allows the company to eliminate confusing language that has bogged down the label information since it launched Afrezza.
“The language really restricted our ability to truly articulate the PK-PD (pharmacokinetic/pharmacodynamic) activity of the product,” he said, adding the company has been working on getting the label updated for about two and a half years.
MannKind is based in California and has a large manufacturing facility in Danbury.
Investors welcomed the news and the stock rose 7.8 percent to $2.34 per share on Monday. In late trading Tuesday, the stock rose more than 20 percent to $2.81 per share.
Castagna highlighted other company milestones during the call. On Sept. 29, Afrezza began its first pediatric trial. It will also file soon with Brazil to have the product sold and marketed there, the first of several international markets in which MannKind intends to sell Afrezza.
Castagna said the company is looking to hire a chief marketing officer soon. MannKind has made several top-level management moves this year. Castagna, 40, took over as CEO from Matthew Pfeffer in May. Steven Binder was named CFO and Patrick McCauley the chief commercial officer in July.
“We will pull our sales force together to make sure we focus them and get good execution happening here in Q4 and get ready for 2018,” he said.
In addition, Castagna said the FDA approved a glucose monitoring system that could spur sales to Type 2 diabetes customers. He said current MannKind sales are evenly split between Type 1 and Type 2 diabetes patients, although 95 percent of overall diabetes patients have Type 2.
“Being able to check your blood sugar without pricking your finger six or seven times a day will make it easier for people to figure out how to manage their glucose control,” he said.
The updated label information includes new clinical data that was presented at the American Diabetes Association’s 76th Scientific Sessions in June 2016.
“These data articulate the rapid-acting nature of Afrezza to address post-prandial hyperglycemia, setting it apart from other mealtime options available to help patients maintain greater control over their blood glucose levels,” Satish Garg of the Barbara Davis Center for Diabetes at the University of Colorado, said in a statement.
cbosak@hearstmediact.com; 203-731-3338
By Chris Bosak Published 3:45 pm, Tuesday, October 3, 2017
www.newstimes.com/business/article/FDA-approves-new-label-language-for-Afrezza-12250087.php
MannKind received FDA approval to update the label on its inhalable insulin product, Afrezza, in a move that will make it easier to market the drug, the company announced this week.
The new label will clarify the starting and mealtime dosages, in addition to listing the initial and peak effects of the drug.
“It’s a pivotal moment in the history of the company,” CEO Michael Castagna said during a conference call on Monday. He said the labeling allows the company to eliminate confusing language that has bogged down the label information since it launched Afrezza.
“The language really restricted our ability to truly articulate the PK-PD (pharmacokinetic/pharmacodynamic) activity of the product,” he said, adding the company has been working on getting the label updated for about two and a half years.
MannKind is based in California and has a large manufacturing facility in Danbury.
Investors welcomed the news and the stock rose 7.8 percent to $2.34 per share on Monday. In late trading Tuesday, the stock rose more than 20 percent to $2.81 per share.
Castagna highlighted other company milestones during the call. On Sept. 29, Afrezza began its first pediatric trial. It will also file soon with Brazil to have the product sold and marketed there, the first of several international markets in which MannKind intends to sell Afrezza.
Castagna said the company is looking to hire a chief marketing officer soon. MannKind has made several top-level management moves this year. Castagna, 40, took over as CEO from Matthew Pfeffer in May. Steven Binder was named CFO and Patrick McCauley the chief commercial officer in July.
“We will pull our sales force together to make sure we focus them and get good execution happening here in Q4 and get ready for 2018,” he said.
In addition, Castagna said the FDA approved a glucose monitoring system that could spur sales to Type 2 diabetes customers. He said current MannKind sales are evenly split between Type 1 and Type 2 diabetes patients, although 95 percent of overall diabetes patients have Type 2.
“Being able to check your blood sugar without pricking your finger six or seven times a day will make it easier for people to figure out how to manage their glucose control,” he said.
The updated label information includes new clinical data that was presented at the American Diabetes Association’s 76th Scientific Sessions in June 2016.
“These data articulate the rapid-acting nature of Afrezza to address post-prandial hyperglycemia, setting it apart from other mealtime options available to help patients maintain greater control over their blood glucose levels,” Satish Garg of the Barbara Davis Center for Diabetes at the University of Colorado, said in a statement.
cbosak@hearstmediact.com; 203-731-3338