By Natalie Grover (SOURCE)

Successful late-stage data on Shire Plc’s, long-acting preventative treatment for hereditary angioedema (HAE) brings the Dublin-based drugmaker one step closer to U.S. approval, it said on Thursday.

U.S.-listed shares of the rare disease drugmaker, which already sells several HAE treatments, were up about 3.4 percent at $188.23 in late-morning trading.

The drug, lanadelumab, which is expected to generate more than $2 billion in peak sales will help Shire protect and grow its existing HAE franchise, which accounts for about 10 percent of its profit, analysts said.

Patients with HAE suffer from recurrent episodes of severe swelling, typically in the extremities, gastrointestinal tract and upper airways. It affects about one in 50,000 people, according to the U.S. National Institutes of Health.

Existing treatments in the United States are either injections for acute attacks or short-acting intravenous infusions administered twice a week.

In Shire’s late-stage study, three dosing arms of lanadelumab (150 or 300 mg every four weeks or 300 mg every two weeks) were tested against a placebo in 125 patients.

Treatment with the drug induced a statistically significant reduction in attacks across all regimens, regardless of baseline attack rate, Shire said.

In particular, the 300 mg dose reduced the monthly attack rate by 87 percent versus a placebo when given every two weeks. 

Data also showed that a significantly higher proportion of patients on lanadelumab were attack free for the 26-week study. 

Given lanadelumab’s compelling efficacy and advantage over existing treatments, Deutsche Bank analysts said they expected it to dominate and significantly expand the current $1.8 billion HAE prophylaxis market. 

The U.S. Food and Drug Administration has already granted the drug – which Shire acquired through its $5.9 billion buyout of Dyax in 2016 – “orphan drug” and “breakthrough therapy” designations.

Shire said it planned to submit a U.S. marketing application for lanadelumab by late 2017/early 2018. The company also expects to submit an EU application in the first half of next year, pending regulatory discussions.

On a conference call with analysts, Shire said it was still analyzing the dataset and did not provide any clarity on pricing.

Shire’s existing HAE drugs include Kalbitor, Cinryze and Firazyr. Other FDA-approved treatments include CSL Behring’s Berinert and Valeant Pharmaceuticals International Inc’s, Ruconest.

Shire’s UK-listed shares were up 1.7 percent at 4814.5 pence.

Shares of U.S. drugmaker BioCryst Pharmaceuticals Inc, which is developing an oral HAE drug, were up about 6 percent.

(Reporting by Natalie Grover in Bengaluru; Editing by Saumyadeb Chakrabarty and Martina D’Couto)

389 thoughts on “Shire’s Swelling Disorder Drug Moves Closer to U.S. Approval”

  1. Pingback: lasix renogram
  2. Pingback: xenical 120mg uk
  3. Pingback: bimatoprost lcms
  4. Pingback: domperidone msds
  5. Pingback: valacyclovir dog
  6. Pingback: cialis sales
  7. Pingback: Google
  8. Pingback: what cialis does
  9. Pingback: virectin vs viagra
  10. Pingback: Google
  11. Pingback: viagra pills
  12. Pingback: Kidney Infection
  13. Pingback: male sex toys
  14. Pingback: zeytinburnu escort
  15. Pingback: sports
  16. Pingback: happyluke
  17. Pingback: happyluke
  18. Pingback: ucuz escort
  19. Pingback: maltepe escort
  20. Pingback: happyluke
  21. Pingback: thrusting rabbit
  22. Pingback: mersin escort
  23. Pingback: Takeout Food
  24. Pingback: fun88
  25. Pingback: prostate milking
  26. Pingback: rabbit vibrator
  27. Pingback: best vagina pump
  28. Pingback: about
  29. Pingback: MILF Porn
  30. Pingback: ground leases
  31. Pingback: lotto vip
  32. Pingback: huay
  33. Pingback: huge dildo review
  34. Pingback: Dank Cartridges
  35. Pingback: sultangazi escort
  36. Pingback: 99defi Blockchain
  37. Pingback: vehicle movements
  38. Pingback: site de streaming
  39. Pingback: french streaming
  40. Pingback: french streaming
  41. Pingback: Here
  42. Pingback: best sex toys
  43. Pingback: male masturbator
  44. Pingback: petit school
  45. Pingback: 안전놀이터
  46. Pingback: 머니상
  47. Pingback: stromectol 6 price
  48. Pingback: Thc oil cartridge
  49. Pingback: mr proper
  50. Pingback: BUY MESCALINE
  51. Pingback: Holyhead School
  52. Pingback: mp3juices
  53. Pingback: Referencement web
  54. Pingback: Maasai tribe kenya
  55. Pingback: best male sex toys
  56. Pingback: aromatherapy oils
  57. Pingback: ivermectin 6 uses
  58. Pingback: web development
  59. Pingback: sig p320x carry
  60. Pingback: magic mushrooms
  61. Pingback: magic mushrooms
  62. Pingback: juul pods for sale
  63. Pingback: pallas cat
  64. Pingback: Thc vape oil
  65. Pingback: Travelmonke Tours
  66. Pingback: the stock market
  67. Pingback: buy pills florida
  68. Pingback: RissMiner
  69. Pingback: dizziness
  70. Pingback: bitcoin
  71. Pingback: how to make love
  72. Pingback: beretta guns
  73. Pingback: pocket masturbator
  74. Pingback: babami sikin benim
  75. Pingback: BUY DMT ONLINE
  76. Pingback: pioneer arms ak-47
  77. Pingback: Patek Philippe
  78. Pingback: pharmacy Canada
  79. Pingback: MUT
  80. Pingback: happyLuke
  81. Pingback: buy amoxil
  82. Pingback: lasix 80 mg price
  83. Pingback: buy gabapentin usa
  84. Pingback: plaquenil medicine
  85. Pingback: priligy for sale
  86. Pingback: provigil
  87. Pingback: cost of albuterol
  88. Pingback: azithromycin 250
  89. Pingback: 200mg provigil
  90. Pingback: ivermectin 3
  91. Pingback: buying ventolin uk
  92. Pingback: buy azithromycin
  93. Pingback: getzq.com
  94. Pingback: mining rigs
  95. Pingback: www.happyruck.com
  96. Pingback: Artvin Gazette
  97. Pingback: dankwood
  98. Pingback: vape juice
  99. Pingback: mallrats
  100. Pingback: sexy blindfold
  101. Pingback: Spore Syringe
  102. Pingback: Buy 3L GBL Cleaner
  103. Pingback: ecigarettes
  104. Pingback: barrett gun store
  105. Pingback: m17
  106. Pingback: stiiizy store
  107. Pingback: stiiizy cartridge
  108. Pingback: zip 22 for sale
  109. Pingback: uca.com.vn
  110. Pingback: Source
  111. Pingback: shrooms for sale
  112. Pingback: online software
  113. Pingback: anal plugs
  114. Pingback: suction cup dildos
  115. Pingback: divorce lawyers
  116. Pingback: Wr250r
  117. Pingback: male masturbator
  118. Pingback: silicone vibrators
  119. Pingback: keltecweapons com
  120. Pingback: sbgv245 for sale
  121. Pingback: vape carts
  122. Pingback: krt disposable
  123. Pingback: gamma labs website
  124. Pingback: silicone vibrators
  125. Pingback: Hi-Point carbine
  126. Pingback: bitcoin api wallet
  127. Pingback: nolvadex order
  128. Pingback: molnupiravir merck
  129. Pingback: baricitinib moa
  130. Pingback: online vvc
  131. Pingback: scrap car removal
  132. Pingback: meritroyalbet
  133. Pingback: meritking
  134. Pingback: meritroyalbet
  135. Pingback: meritroyalbet
  136. Pingback: meritroyalbet
  137. Pingback: elexusbet
  138. Pingback: refinance mortgage
  139. Pingback: Glock g44
  140. Pingback: Beretta m9a3
  141. Pingback: lottovip
  142. Pingback: baymavi
  143. Pingback: baymavi
  144. Pingback: glock 43x
  145. Pingback: tombala siteleri
  146. Pingback: how to use a dildo
  147. Pingback: male stroker
  148. Pingback: meritroyalbet
  149. Pingback: eurocasino
  150. Pingback: tiktok mp3
  151. Pingback: PS5 for Sale
  152. Pingback: fulgurite for sale
  153. Pingback: glock 43x for sale
  154. Pingback: Glock 35 for Sale
  155. Pingback: suction cup dildos
  156. Pingback: beginner anal toys
  157. Pingback: go extract
  158. Pingback: anita
  159. Pingback: app for laptop
  160. Pingback: MFT Token
  161. Pingback: estrella damm
  162. Pingback: Herbal Incense
  163. Pingback: madridbet giriş
  164. Pingback: packaging
  165. Pingback: glock 28
  166. Pingback: Glock 19 for sale
  167. Pingback: business in canada
  168. Pingback: Krt carts
  169. Pingback: junk car towing
  170. Pingback: FLINTLOCK PISTOL
  171. Pingback: Marijuana delivery
  172. Pingback: Food in Nanaimo
  173. Pingback: zwitsal
  174. Pingback: scrap car removal
  175. Pingback: listen here
  176. Pingback: Latest News
  177. Pingback: Watermelon haupia
  178. Pingback: Haupia strain
  179. Pingback: Bubble hash
  180. Pingback: Moroccan hash
  181. Pingback: Litto
  182. Pingback: madridbet
  183. Pingback: eurocasino
  184. Pingback: bahis siteleri
  185. Pingback: 1alienate
  186. Pingback: meritroyalbet
X